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Celiac.com 06/27/2024 - For people with celiac disease who are attempting to maintain a gluten-free diet, there are some potential new treatment options on the horizon. Managing celiac disease means adhering to a strict gluten-free diet. Many people with celiac disease, who are attempting to maintain a gluten-free diet, continue to have regular or intermittent symptoms. In fact, research shows that is estimated that up to 50% of celiac disease patients have persistent symptoms while on the gluten-free diet. The most common reason for persistent symptoms is continuing to ingest gluten, often by accident. A clinical trial is currently evaluating the effectiveness of TAK-062 in reducing symptoms and improving small intestinal damage caused by gluten exposure. Here's what you need to know. Study Aim The main aim of the trial is to see how well TAK-062 reduces celiac-related symptoms, and improves small intestinal damage from gluten exposure, in people with celiac disease. Participants will receive either TAK-062 or a placebo to measure its impact against the control group. New Study on TAK-062 for Celiac Disease A new clinical trial is testing TAK-062, a potential treatment for people with celiac disease who are trying to follow a gluten-free diet. Here are the main points about who can join and who can't. Who Can Join the Study? Understanding of GFD: You need to know a lot about gluten-free diets. This will be checked by a test and confirmed by the study investigator. Symptoms: You must have at least one moderate or severe celiac-related symptom on three or more days in a week during the screening period. Diet History: You should have been trying to follow a gluten-free diet for at least 12 months. Intestinal Damage: You must have small intestinal damage, shown by a specific measure from a biopsy. Genetic Markers: You need to have the HLA-DQ2 and/or HLA-DQ8 genetic markers. Overall Health: You should be in good health based on a medical check-up. Body Mass Index (BMI): Your BMI should be between 16 and 45 kg/m². Consistency: You must be able to keep the same diet and medication routines during the study. Who Can't Join the Study? Other GI Disorders: If you have other inflammatory gut diseases or uncontrolled autoimmune diseases, you can't join. Immunosuppressant Use: If you’ve used systemic immunosuppressants or corticosteroids recently, you’re not eligible. Digestive Supplements: Using over-the-counter digestive enzymes or supplements for gluten digestion disqualifies you, except for lactase. Symptom Diary: You need to complete at least 75% of the symptom diary during the run-in period. Microscopic Colitis: Active microscopic colitis or a recent history of it disqualifies you. Refractory celiac disease: If you have type 2 refractory celiac disease or ulcerative jejunitis, you can't join. NSAIDs: Chronic use of NSAIDs, except for low-dose aspirin, disqualifies you. Villous Abnormalities: Using medications that cause villous damage means you can't join. Recent GI Treatments: Recent use of certain GI treatments or supplements disqualifies you. Severe Infections: A severe enteric infection in the past six months disqualifies you. Endoscopy Issues: If you can’t have an endoscopy, you can’t join. Food Allergies: Allergies to ingredients in the study food bar disqualify you. Drug Reactions: History of reactions to aminoglycosides disqualifies you. Infections: HIV, hepatitis B or C infections disqualify you. COVID-19: Testing positive for COVID-19 with symptoms that affect the study disqualifies you. Wheat/Gluten Allergy: Known wheat or gluten allergies disqualify you. Ingredient Sensitivity: Sensitivity to TAK-062 or placebo ingredients disqualifies you. Active Cancer: Current or recent cancer treatment disqualifies you, except for certain early-stage cancers. This trial is another of many that offers hope for a new therapeutic approach for managing celiac disease, potentially improving the quality of life for many individuals struggling with this condition. Find more information at classic.clinicaltrials.gov

Celiac.com 06/19/2024 - For adults with celiac disease, managing their condition often means adhering to a strict gluten-free diet. Research shows that is estimated that up to 50% of celiac disease patients have persistent symptoms while on the gluten-free diet. The most common reason for persistent symptoms is continuing to ingest gluten. However, researchers are exploring new treatments that might help. One such promising development is a clinical trial assessing the safety and efficacy of TPM502. Study Purpose The primary goal of this clinical trial is to evaluate the safety and pharmacodynamic effects of TPM502 in adults with celiac disease. Specifically, the trial aims to determine: Whether TPM502 is safe and well-tolerated To reveal whether TPM502 can induce modifications in parameters that suggest it may help induce tolerance to gluten. Study Design This is a multi-center, double-blind, randomized, placebo-controlled Phase 2a study to evaluate the safety, tolerability, and PD effects of two infusions of TPM502 in adult patients diagnosed with celiac disease. Participants in this study will undergo a one-day gluten challenge during both the screening phase and after the administration of TPM502 or a placebo. They will receive two infusions of TPM502 or a placebo, administered two weeks apart. This approach will help researchers assess the immediate effects of TPM502 on the body's response to gluten. Patient participation in the study comprises 3 phases: screening period, treatment period and follow-up period. Patients fulfilling the eligibility criteria will be randomized to receive two infusions of TMP502 (or placebo) at the same dose level. Patients will undergo a second GC one week after the second infusion of TPM502. The study includes 4 cohorts of patients, each cohort will receive escalating doses of TPM502 (or placebo). Upon completion of the 3rd cohort, a lower dose can be investigated, if deemed relevant. Inclusion Criteria To be eligible for the trial, participants must meet several criteria: A documented biopsy-confirmed diagnosis of celiac disease or significant markers like tissue transglutaminase levels above 10 times the upper limit of normal and positive IgA anti-endomysial antibody at the time of diagnosis. Normal levels of anti-tissue transglutaminase 2 antibodies at screening. Elevated serum IL-2 levels following the gluten challenge at screening Adherence to a gluten-free diet for at least six months. Well-controlled celiac disease with mild or no ongoing symptoms. HLA-DQ2.5 positivity. Exclusion Criteria Certain conditions will exclude potential participants from the study, including: Known or suspected refractory celiac disease. Severe symptoms following previous gluten challenges. HLA DQ8 positivity Active gastrointestinal diseases like gastroesophageal reflux disease, esophagitis, peptic ulcer, microscopic colitis, or irritable bowel syndrome that might interfere with symptom assessment. History of or active inflammatory bowel diseases like Crohn’s disease or ulcerative colitis. Known wheat allergy. Hypersensitivity to intravenous iron preparations or other components of TPM502 or the placebo. This trial represents a significant step forward in potentially expanding the treatment options available for individuals with celiac disease, offering hope for improved management of the condition beyond strict dietary restrictions. Read more at trials.celiac.org

Celiac.com 08/17/2023 - KAN-101, the most recent drug designed to induce immune tolerance to wheat gluten, has proven safe and tolerable in the Phase 1 stage of testing. Now the hard work starts. The drug has shown promise for treating celiac disease, an autoimmune condition where the body reacts negatively to gluten in the small intestines. The drug, developed by Anokion, targets the liver to promote immune tolerance to gluten in people with celiac disease. KAN-101 Demonstrated Safety and Pharmacokinetic Potential In the first-in-human phase 1 ACeD trial, KAN-101 demonstrated safety and pharmacokinetic potential. The trial involved 41 adult patients with biopsy-confirmed celiac disease, all with the HLA-DQ2.5 genotype, which is associated with celiac disease. The patients received different doses of KAN-101 through intravenous administration. No Serious Adverse Events or Dose-limiting Toxicities Results showed that the drug had acceptable safety, with no serious adverse events or dose-limiting toxicities. Common mild to moderate side effects included nausea, diarrhea, abdominal pain, and vomiting, which were consistent with celiac disease symptoms. KAN-101 rapidly cleared from the patients' systems within approximately 6 hours, and there was no accumulation on repeated dosing. Deborah Geraghty, CEO of Anokion, expressed excitement about the drug's potential to induce immune tolerance to gluten, providing a durable treatment effect for celiac disease patients. With celiac disease currently lacking an FDA-approved treatment option, KAN-101 could be a game-changer. The research team plans to further analyze KAN-101's efficacy and safety in human patients, particularly with biomarker responses from a gluten challenge, at doses of 0.6 mg/kg or higher in those with celiac disease. If successful, KAN-101 could significantly impact the lives of those with celiac disease by providing a viable and effective treatment option. While the early testing is encouraging, it's a long haul from Phase 1 to full approval, and so far, no drug designed to treat celiac disease has made the journey. The failures are legion. So, celiac sufferers should take this news with a grain of salt. Read more at HCPlive.com

Celiac.com 05/15/2023 - Biotechnology company Immunic, Inc., focuses on developing oral, small molecule therapies for chronic inflammatory and autoimmune diseases, including celiac disease. Celiac disease is an autoimmune disorder that affects approximately 1% of people globally. People with celiac disease have an abnormal immune response to gluten, a protein found in wheat, barley, and rye. This abnormal immune response damages the lining of the small intestine, leading to malabsorption and other serious complications. The company recently announced positive results from the Part C portion of its Phase 1 clinical trial of IMU-856 in treating patients with celiac disease. The trial consisted of 36 patients with celiac disease who were randomized to receive placebo or one of two doses of IMU-856 (80 mg or 160 mg) for four weeks, followed by two weeks of gluten challenge. The trial assessed the protection of gut architecture, reduction of gluten-induced intestinal damage, improvement of patients' symptoms related to gluten exposure, dose-dependent changes in biomarker responses, and enhancement of nutrient absorption. The trial results showed that patients treated with IMU-856 had a dose-dependent reduction in gluten-induced damage to their intestinal villi, the small, finger-like projections in the small intestine that play a key role in nutrient absorption. The results also showed that IMU-856 restored the absorption of essential nutrients, such as vitamin B12, for red blood cell formation and the functioning of the brain and nervous system. Immunic believes the clinical evidence supports IMU-856's ability to re-establish proper gut cell renewal, which could prove useful in treating other gastrointestinal diseases. Patients treated with IMU-856 also saw improvement in disease-related symptoms such as bloating and tiredness, and the treatment was observed to be safe and well-tolerated. IMU-856's ability to re-establish proper gut cell renewal, observed in preclinical studies, translates into clinical benefits for patients with celiac disease. Most importantly, the observed protection of intestinal villi from gluten-induced damage, independent of celiac-specific targeting immune mechanisms, seems to be unique among proposed therapeutic approaches, and may be applicable to other gastrointestinal diseases. Immunic is now preparing for clinical phase 2b testing of IMU-856 in ongoing active celiac disease, while also considering other potential clinical applications for this first-in-class and orally available molecule. The positive results from the Phase 1 clinical trial of IMU-856 offer some hope for the development of a new therapeutic approach to treating celiac disease and other gastrointestinal disorders. The trial's success represents a significant milestone in the effort to develop safe and effective treatments for patients with celiac disease, and other chronic inflammatory and autoimmune conditions. The company believes that this data set provides initial clinical proof-of-concept for a new therapeutic approach to gastrointestinal disorders by promoting the regeneration of bowel architecture. Now, the story of a promising new celiac drug treatment is a story familiar to many of us. So far, the story has always ended the same way: the promising drug fails in the end. Here's hoping this one ends more happily. Stay tuned for more on this and related stories.

Celiac.com 01/23/2023 - Celiac disease is an auto-immune condition in which eating gluten damages the intestinal lining of the gut. Currently, the only proven celiac treatment is a gluten-free diet. However, perfect gluten-free compliance is hard to sustain, and accidental gluten exposure is common. Studies show that even the most diligent patients likely get exposed to small doses of gluten on a regular basis. Because of this, there is substantial interest in developing new drugs and therapies to treat celiac disease, usually in tandem with an existing gluten-free diet. A team of researchers recently set out to review existing and upcoming clinical trial programs for pharmacologic agents for celiac disease. The research team included Michael Klonarakis; Christopher N. Andrews; Maitreyi Raman; Remo Panaccione; and Christopher Ma. They are variously affiliated with theDepartment of Medicine, University of Calgary, Calgary, Alberta, Canada; the Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada; the Alberta Collaboration of Excellence for Nutrition in Digestive Diseases, Calgary, Alberta, Canada; and the Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada. Their team conducted a narrative review by searching MEDLINE, Embase, the Cochrane CENTRAL Library and clinicaltrials.gov. They then summarized the pathophysiology of celiac disease and the specific steps that could be favorably influenced by pharmacologic treatment, and then assessed the evidence in favor of current and future drug targets, including trials of peptidases, gluten sequestrants, tight junction regulators, anti-transglutaminase 2 therapies, immune tolerizing agents, advanced biologics and small molecules, and microbiome-targeted strategies. Finally, they highlighted the variables key to conducting successful celiac disease trials, including finding suitable study groups, evaluating results in the context of a gluten challenge, and interpreting celiac-specific clinical and histologic outcomes. After balancing these factors and accurately appraising the evidence, the team described potential celiac disease pharmacotherapies of the future. From their assessment, the team concludes that celiac disease sufferers need pharmacologic options, either to complement a gluten-free diet in the case of gluten exposure, or for treating refractory disease. With numerous drugs currently in development, the team expects approvals for the first generation of celiac drug treatments within the next 5 years. Color me skeptical, but the idea that new and effective treatments for celiac disease are only 5 years away is one we've heard for at least 15+ years now. The failures are legion. However, any major step forward will give people with celiac disease much to look forward to, so here's hoping. Stay tuned for more on this and related stories. Read more in Alimentary Pharmacology & Therapeutics

Celiac.com 12/19/2022 - Major drug firms Takeda, Zedira, and Dr. Falk Pharma GmbH, have announced a collaboration and licensing agreement to develop ZED1227/TAK-227, a Phase 2b investigational drug for the treatment of celiac disease. According to the Takeda press release, TAK-227 is a selective, oral small molecule designed to inhibit tissue transglutaminase (TG2), an enzyme that generates immunogenic gluten peptide fragments upon the breakdown of gluten in the gut. TAK-227 is a potential first-in-class therapy designed to prevent the immune response to gluten in celiac disease. It works by "targeting the dysregulated transglutaminase to prevent mucosal damage in the small intestine by preventing the body’s immune response to gluten, a disease process mediated by activation of gluten-specific T cells," according to Takeda A Phase 2a proof-of-concept study published in the New England Journal of Medicine showed that, in addition to being safe and well tolerated during a six-week gluten challenge, TAK-227 conveyed a protective effect on the duodenal mucosa, and celiac-related symptoms. “Patients with celiac disease urgently need appropriate therapeutic options to manage the significant negative impacts of the disease on health and daily quality of life,” said Roland Greinwald, Ph.D., Managing Director Medicine & Pharmaceutics at Dr. Falk Pharma The collaboration agreement gives Takeda exclusive license to develop and commercialize ZED1227/TAK-227 in the United States and countries outside of Europe, Canada, Australia and China, and adds a third investigational drug to Takeda’s development pipeline for celiac disease treatment. Obviously, any drug that can help to prevent mucosal damage in the gut when people consume gluten will be interesting and potentially helpful to a great many people with celiac disease. We'll need to keep an eye on the details, especially any side-effects, and the degree of protection, etc. to know for sure. Still, the deal is important because it reiterates the companies' commitment to this celiac disease drug, and to continue doing the heavy lifting in developing other drugs to treat celiac disease. Stay tuned for more on this and related stories. Read more in the Takeda Press Release

Celiac.com 11/21/2022 - Following a gluten-free diet for life can be difficult, Most celiacs on a gluten-free diet get exposed to gluten on a regular basis, especially if they eat in restaurants. Currently, a gluten-free diet is the only effective treatment for celiac disease. Because of this, there is substantial interest in drug therapies that can help to protect celiacs on a gluten-free diet, and, ideally, free them from a strict gluten-free diet. There are a number of drugs still in the pipeline that promise the former, at least. So what's the status of the multiple new therapies that are under investigation? To answer this question, a team of researchers recently set out to review existing and upcoming clinical trial programs for pharmacologic agents for celiac disease. The team conducted a narrative review using searches of MEDLINE, Embase, the Cochrane CENTRAL Library and clinicaltrials.gov. In their review, the team summarizes the pathophysiology of celiac disease, and the specific steps that might help to speed pharmacologic treatment. They also assess the evidence in support of current and future drug targets, including trials of peptidases, gluten sequestrants, tight junction regulators, anti-transglutaminase 2 therapies, immune tolerizing agents, advanced biologics and small molecules, and microbiome-targeted strategies. The team also spotlights the special challenges of conducting celiac disease trials, including identifying appropriate study populations, assessing results in the context of a gluten challenge, and interpreting celiac disease-specific clinical and histologic outcomes. Understanding these factors is crucial for accurately appraising the evidence. Finally, they outline what the future of celiac disease therapy may hold with the introduction of viable drug treatments. There is a definite need for drug options for treating celiac disease, either for accidental or intentional gluten exposures, as part a gluten-free diet, or for refractory disease. The big takeaway, is that, according to the team's reading of the data, multiple promising celiac disease drug therapies are in development, and these trials are likely to lead to approvals for the first generation of pharmacologic agents for celiac disease within the next 5 years. Color us skeptical, but that seems a pretty bullish view, especially given the crowded graveyard of once seemingly promising celiac drug therapies, especially the very recent demise of the highly touted Larazotide. Basically, we'll believe in successful drug treatments for celiac disease when we see a successful product make it to celiacs. Meanwhile, stay tuned for more on this and related stories. Read more in Aliment Pharmacol Ther. 2022;55(10):1277-1296 The research team included Michael Klonarakis, Christopher N. Andrews, Maitreyi Raman, Remo Panaccione and Christopher Ma. They are variously affiliated with theDepartment of Medicine, University of Calgary, Calgary, Alberta, Canada; the Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada; the Alberta's Collaboration of Excellence for Nutrition in Digestive Diseases, Calgary, Alberta, Canada; and the Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.

Celiac.com 09/21/2022 - The dream of creating a safe, effective drug that can help people with celiac disease to tolerate small amounts, or perhaps even large amounts, of gluten. Until its recent failure, 9 Meters' larazotide was the only celiac drug in Phase 3 clinical trials. The recent discontinuation of larazotide, based on disappointing interim results, highlights the unmet need for effective alternatives to a gluten-free diet for treating celiac disease. Larazotide's failure also opens the doors for current and future Phase 1 and Phase 2 celiac therapies to be first-to-market. It also highlights the lack of a good lineup of potential new drugs. The reality is that, with the collapse of several once promising candidates, the bench for viable alternative celiac disease treatments is shallow, at best. Current Celiac Disease Pipeline Therapies Include: Latiglutenase (ImmunogenX) PRV-015 (Provention Bio, Inc. with Amgen) TAK-101 (Takeda Pharmaceuticals) ZED-1227 (ZEDIRA GmbH) KAN-101 (Anokion SA) In an effort to assess the current and future alternatives for treating celiac disease without a gluten-free diet, data marketing company Spherix recently interviewed one-hundred US gastroenterologists, and conducted eight qualitative interviews to compile a report on the issue. Spherix has issued a recent report on the form gastroenterologists engaged in a thorough review of these pipeline product descriptions (based on publicly available clinical information for each product). The report assesses celiac diagnostic and treatment trends emerging, as well as physician reactions to potential therapies in the pipeline. The 2022 report reveals a greater sense of urgency from gastroenterologists versus the 2021 report. Indeed, the number of respondents in the 2022 survey who say that their celiac patient load has increased in the past year, is up by 60% over 2021. Read more at PRNewswire.com

Celiac.com 07/26/2022 - Previous drugs designed to induce tolerance to gliadin have met with failure. Will the latest effort fare any better? In people with celiac disease, gliadin-specific T cells drive an adverse immune response to gluten peptides, which can cause symptoms, long-term gut damage, and other related conditions. Currently, the only treatment for celiac disease is a gluten-free diet. A new drug, KAN-101, designed to treat celiac disease by inhibiting a key celiac disease biomarker, has received fast track status from the FDA ahead of Phase 2 Trials slated for the second half 2022. Designed by Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, KAN-101 has been found to be safe, well-tolerated, and to provide the proper immune responses. KAN-101 is designed to induce tolerance to gliadin, a core component of gluten, through natural pathways in the liver. The Phase 1, randomized, double-blind, placebo-controlled trial enrolled a total of 41 individuals with celiac disease on a gluten-free diet in both single-ascending dose (SAD) and multi-ascending dose (MAD) cohorts. Findings from the Phase 1 trial showed that treatment with KAN-101 was safe and tolerated, and successfully reduced T cell responses following gluten challenge. The primary endpoint of the Phase 1 trial is to assess the safety and tolerability of KAN-101, with secondary endpoints to assess KAN-101 serum concentrations and pharmacokinetics. Additional end points include the assessment of cytokines critical to both innate and adaptive immunity, T cell responses, and other serum cytokines and celiac disease symptoms. Patients who recieved KAN-101 experienced dose-dependent reductions of gluten-induced plasma IL-2, a cytokine that is elevated in celiac patients after gluten ingestion, and which reflects severity of acute symptoms. Patients who received the 0.6mg/kg dose experienced statistically significant reductions of IL-2, compared to other groups Administration of KAN-101 did not increase gut-homing CD8 T cell responses after gluten challenge, an indicator of immune response to gluten exposure in patients with celiac disease. Stories about new drugs designed to induce tolerance to gluten always cause great excitement within the celiac disease community. However, previous drugs designed to induce tolerance to gliadin have met with failure. Will the latest effort fare any better? Stay tuned for more as KAN-101 moves into its Phase 2 trial later this year. Read more at Businesswire.com

Celiac.com 07/04/2022 - The Food and Drug Administration (FDA) has issued a set of new guidelines for companies doing celiac disease drug trials. The agency noted that the guidance is intended only to provide clarity regarding existing requirements, and should be viewed solely as recommendations, unless they mention specific regulations or laws. The FDA directs sponsors of trials for clinical drugs to ensure the following regarding celiac disease patients on a gluten-free diet: Trial population Patients should undergo diagnostic esophagogastroduodenoscopy, with multiple biopsies to confirm celiac diagnosis. The biopsies should include one or two samples of the duodenal bulb and at least four samples of the distal duodenum. To avoid inclusion of patients whose symptoms are not celiac-related, patients should receive esophagogastroduodenoscopy screening with biopsy to ensure they meet histologic eligibility criteria at the time of trial enrollment. Patients should be symptomatic at baseline, based on enrollment criteria, to allow for evaluation of symptom improvement. Prior to trail enrollment and for the full duration, patients should follow to a strict gluten-free diet with input from trained dietitians. Trial design The FDA recommends using randomized, double-blind, placebo-controlled trial design. Before randomization of participants, sponsors should include a screening period to confirm histologic eligibility criteria, document clinical signs and symptoms, and train patients and/or providers in collecting clinical outcome assessment data. Trial duration and outcome assessments should be informed by the therapy goal, expected drug onset of action and the time frame in which clinical benefit is observable. The FDA recommends a placebo-controlled treatment period of at least 52 weeks for drugs intended for chronic use, with continued patient adherence to a gluten-free diet. Efficacy assessments for both clinical and histologic endpoints may be evaluated at week 24, and esophagogastroduodenoscopy with biopsy should be performed at week 52 to assess durability of response. Sponsors should make sure their patients follow a gluten-free diet for the complete treatment period. Efficacy and clinical outcome assessments Trails intended to support market approval should include coprimary endpoints to assess a drug’s effect on clinical signs, symptoms and related underlying mucosal condition. The FDA also recommends a pre-specified secondary endpoint to determine the number of patients who see improvement of clinical signs, symptoms and mucosal inflammation. Trial sponsors should seek FDA input early, when critical milestones are met, and throughout drug development. Sponsors should also identify disease and treatment burdens using patient input. To better assess symptom severity and event-related signs and symptoms, sponsors should ask patients to rate their worst experience and frequency of a specific sign or symptom over a 24-hour period. Statistical and safety considerations To be demonstrate efficacy, trial results should demonstrate statistical significance for both clinical and histological endpoints, and analyses should include all randomized patients. Sponsors should assess gluten-free diet adherence, which could alter efficacy data. Moreover, sponsors should talk with patients about the importance of following a strict gluten-free diet, since the benefit of the drug is still unknown. To assess the safety of drugs intended for long-term use, patients should be follow the intended market dosage for at least one year. The FDA recommends that sponsors include safety analyses to compare risk and confidence intervals in treatment groups. Read the full recommendations at FDA.gov

Celiac.com 04/09/2021 - We get a lot of questions from celiac community members wondering if certain products are gluten-free. One question we see a lot is about over-the-counter allergy medications, especially Claritin. Specifically, is Claritin gluten-free and safe for people with celiac disease? The short answer is yes. All sources we can find indicate that all Claritin products are gluten-free. The information chain starts with a reply from the Claritin Consumer Relations department says that "All forms of Claritin are naturally gluten free...The Claritin Reditabs, Children's Claritin Syrup, and Claritin-D 24 hour are milk/casein free. The Claritin Allergy, Claritin Hives Relief, and Claritin-D 12 hour formulas contain milk or lactose." That is supported by a recent post on Verywellfit.com by Dr. Sanja Jelic, MD, who notes that "all Claritin products are gluten-free." Moreover, dailymed.nlm.nih.gov also lists Claritin as gluten-free. Claritin active ingredients include: Loratadine 5 mg, an antihistamine Inactive ingredients include: Water, Sodium Benzoate, Glycerin, Edetate Disodium, Maltitol, Sodium Phosphate, Monobasic, Phosphoric Acid, Sorbitol, Sucralose. Visit dailymed.nlm.nih.gov for a more extensive list of Claritin and other gluten-free drugs. If you're unsure about the gluten-free status of drugs or prescription medicines, check with your pharmacist.

Celiac.com 08/17/2020 - The case of a man whose celiac disease went into remission after he took an off market drug for alopecia, even though he was eating gluten, is getting some attention from researchers. An alopecia patient at the University Hospitals Leuven, Belgium, tried to control his celiac disease by following a gluten-free diet. After some modest improvement in symptoms, the patient returned to a non-gluten-free diet, and the symptoms returned. The patient chose to continue eating gluten, and to keep an eye on the symptoms. At about that time, he began taking off-label Tofacitinib to treat his alopecia. Tofacitinib is a Janus kinase inhibitor approved for treatment of rheumatoid arthritis and bowel diseases. Tofacitinib inhibits enzymes associated with symptoms of rheumatoid arthritis, but it’s also used to treat alopecia and certain bowel diseases. To the surprise of his clinicians, a follow-up visit showed complete histologic and serologic remission of the man's celiac disease, despite his ongoing consumption of gluten. Blood tests for celiac antibodies all came back in the normal range. The result is intriguing, but is only a single case, and it will require a larger study to reveal whether this might also work in others with celiac disease. Since Tofacitinib has already been approved by the FDA as a safe and effective treatment for several non-celiac conditions, positive studies of it successfully treating celiac disease could mean that people with celiac disease may soon have a new drug option to manage their condition. Still, this case report is only one single patient, and much more research needs to be done before drawing any conclusions about whether this drug will work in others with celiac disease. The clinicians are encouraging further study of the relationship between Tofacitinib and celiac disease remission. At the same time, they advise caution, because Tofacitinib can have potentially serious side effects, and may not be suitable for long-term use. In fact, if Tofacitinib proves useful against celiac disease, it may be especially helpful for people with refractory celiac disease. Read more about the team's report in Annals of Internal Medicine

Celiac.com 07/01/2019 - Drugmakers have pulled the plug on a phase II trial of Nexvax2, a promising drug for treating celiac disease. Pharmaceutical company ImmusanT, said that "results from an interim analysis revealed Nexvax2 did not provide statistically meaningful protection from gluten exposure for celiac disease patients when compared with placebo." That's a lot of fancy language to say that the drug simply didn't work. It did no better than a placebo. If there were any other way to spin it, the company would have spun it. They didn't. That basically means total failure. We've written about Nexvax2 over the years, and followed it through its development. It was promising enough to earn fast-track development status by the FDA. The company's press release reads as follows: ImmusanT Discontinues Phase 2 Clinical Trial for Nexvax2® in Patients With Celiac Disease CAMBRIDGE, Mass. – June 25, 2019 – ImmusanT, Inc., a clinical stage company leveraging its Epitope-Specific Immuno-Therapy™ (ESIT™) platform to deliver first-in-class peptide-based immunomodulatory vaccine therapies to patients with autoimmune diseases, has discontinued the Phase 2 global study for its lead candidate, Nexvax2®, intended as a treatment for celiac disease. Similar to earlier Phase 1 results, Nexvax2 was found to be safe and generally well tolerated. There were no concerning safety issues identified during the study. ImmusanT will be actively investigating data gathered from the trial to further understand this outcome. The company will provide further information once available." So, to boil it down: The drug is safe and well tolerated, but it doesn't work any better than a placebo. The company will not pursue further testing. That's sad news and an ignoble end for a drug that held such high hopes. Few topics have generated as much excitement among celiac sufferers as the tantalizing possibility of a vaccine. Many eagerly hoped for success, while some wouldn't take it on a bet. It's unclear what this means for the technology behind Nexvax 2, as the underlying mechanics for this vaccine, Epitope-Specific Immuno-Therapy (ESIT), were to serve as the platform for future autoimmune treatments. Stay tuned for more on this and related stories.

Celiac.com 01/14/2019 - There are a number of new drugs in development that are designed to treat celiac disease. In addition to a possible vaccine, those drugs include enzymes and other drugs that are designed to reduce or eliminate the body’s adverse reaction to gluten through various mechanisms. Here's a 2019 status update for every drug for treating celiac disease currently in development: ALV003—Created by Alvine Pharmaceuticals, is a combination of two enzymes that break down gluten before it can provoke an immune reaction. The drug is a powder to be dissolved in water and taken before meals. ALV003 passed a phase 2 clinical trial, and results were published in the June 2014 issue of Gastroenterology. Post-trial biopsies showed that ALV003 prevented intestinal damage in 34 volunteers with celiac disease, each of whom ate 2 grams of gluten per day for six weeks, in addition to taking ALV-003. Phase 2b, a 12-week trial, is now underway. AN-PEP (aspergillus niger prolyl endopeptidase)—Created by DSM Food Specialties, AN-PEP is another enzyme that degrades gluten. AN-PEP is believed to work best when taken while gluten is still in the stomach. A 2013 study showed AN-PEP to be safe, but failed to show that the enzyme had any effect, so further study is under way. That study appeared in the World Journal of Gastroenterology. In a 2018 study, AN-PEP extensively degraded gluten concentrations of up to 80,000 mg/kg in rye flour, rye sourdough, and sourdough starter under specific temperatures and pH values, while leaving the microorganisms in the sourdough starter fully intact. ActoBiotics—Created by ActoGenX uses Lactococcus lactis as an expression system to locally secrete bio-therapeutics such as cytokines, antibodies, hormones, etc. Early pre-clinical work with a genetically altered L. lactis secreting a peptide derived from gliadin demonstrated an in vivo suppression of gluten sensitization. Specifically, Huigbregtse et al. engineered L. lactis to secrete a deamidated DQ8 gliadin epitope (LL-eDQ8d) and studied the induction of Ag-specific tolerance in NOD ABo DQ8 transgenic mice [34]. Although apparently not part of the ActoGenX development program, recent work by Galipeau et al. also deserves mention in this context. The group treated gluten-sensitive mice with elafin, a serine protease inhibitor, delivered by the L. lactis vector, and found normalization of inflammation, improved permeability, and maintained ZO-1 expression. There is speculation that this is due to reduced deamidation of gliadin peptide. AVX176—Created by Avaxia Biologics, is an investigational oral antibody drug patented to provide "Antibody Therapy for Treatment of Diseases Associated with Gluten Intolerance." The patent, which expires on May 27 2029. AVX176 provides broad coverage for treating celiac disease using orally administered antibodies produced by Avaxia's proprietary platform technology. BL-7010—by BioLineRx, is a novel co-polymer for the treatment of celiac disease, which significantly reduces the immune response triggered by gluten. This drug has been shown in mice to reduce the immune system response that leads to intestinal damage and villous atrophy in celiac disease. BL-7010 actually binds to the gluten protein, reducing the protein's toxicity.The drug, with the gluten molecule attached, then passes harmlessly through the digestive system to be expelled as stool. BL-7010 has undergone safety testing in humans and was found to be well tolerated. According to BioLineRx, testing will begin in mid-2015 to see if the drug works as expected to diminish gluten's effects on the body. However, BL-7010 is designed to protect only against gluten cross-contamination; it won't allow people with celiac disease to eat large amounts of gluten. CCR9—by Chemocentryx, is a drug called vercirnon, which is also known as Traficet-EN, or CCX282B), and was originally intended for patients with moderate-to-severe Crohn's disease. CCR9 has completed one Phase 2 trial in 67 patients with celiac disease. However, despite the completion of the trial several years ago, no results relating to celiac disease have been made public or published. Egg Yolk Enzyme—Little is known about efforts to develop a celiac treatment that uses egg yolk to coat gluten and allow it to pass through the body undetected, thus preventing an adverse gluten reaction in sensitive individuals. Like most other drugs being developed, this treatment would work to prevent reactions to small amounts of gluten, rather than as a cure for celiac disease. Recent news shows that the egg yolk enzyme is safe for humans. GliadinX (Aspergillus niger)—GliadinX is a dietary supplement with the highest concentration of AN-PEP, Prolyl Endopeptidase (Aspergillus Niger), the most effective enzyme proven to break down gluten in the stomach. This high potency enzyme formulation is specifically designed to break down gliadin. GliadinX does not prevent or cure celiac disease. However, clinical research has shown that it effectively breaks down gliadin into small, harmless fragments before it can reach the small intestine. INN-202 (Larazotide Acetate)—Created by Alba Therapeutics and later acquired by Innovate Pharmaceutical, and renamed INN-202, larazotide acetate works by blocking a protein that carries pieces of gluten across the gut. Results of a phase 2 trial of larazotide acetate appear in the February 2015 edition of Gastroenterology. While INN-202 may greatly reduce the symptoms of gluten exposure in celiacs, it is unlikely that a permit consumption of unlimited amounts of gluten. The U.S. Food and Drug Administration (FDA) has fast-tracked the drug. Phase III clinical trials are currently underway. Results of the trial should be available soon. Nexvax2—Created by ImmusanT, Nexvax2 is touted as a vaccine, but works much like an allergy shot. Nexvax2 combines three proprietary peptides that elicit an immune response in celiac disease patients who carry the immune recognition gene HLA-DQ2. Similar to allergy shots, the vaccine is designed to reprogram gluten-specific T cells triggered by the patient's immune response to the protein. Nexvax2 exposes the immune system to gluten in a controlled way so that immune cells that are usually activated get turned off or eliminated. So far, Nexvax2 has completed a phase 1 trial showing it to be safe, and the company has begun Phase II trials on humans in Australia and New Zealand. Saliva Rothia—Researchers at the Henry M. Golden School of Dental Medicine were looking at how proteins in general break down in saliva when they discovered an enzyme in a bacterium called Rothia that pulverized gluten as if it were Pac Man. That happy accident has led to a new stream of study that has moved beyond petri dishes to study the effect of the so-called ‘subtilisin,’ or protein-ingesting enzyme on the tiny digestive systems of mice. In so doing, they have found another bacterium, B. subtilis, which produces an enzyme similar to the Rothia one and is already safely consumed in Japan in a fermented soybean dish called ‘natto.’ A 2018 Boston University report concludes that “oral Rothia bacteria to gliadin digestion and pharmaceutical modification can protect Sub-A from auto-digestion as well as from acidic insults, thus rendering the usefulness of coated subtilisins as a digestive aid for gluten degradation.” ZED1227—Created by Dr. Falk Pharma and Zedira recently announced the start of phase II clinical trials for the drug candidate ZED1227, a direct acting inhibitor of tissue transglutaminase. ZED1227 molecules work by targeting the dysregulated transglutaminase within the small intestine in order to suppress the immune response to gluten which drives the disease process. Sources: An Update on Every Celiac Disease Drug Currently in Development Inside The Race for a Celiac Disease Treatment Promising Celiac Disease Drugs in the Pipeline Development of drugs for celiac disease: review of endpoints for Phase 2 and 3 trials

Celiac.com 12/31/2018 - Rates of celiac disease are about triple for patients who also suffer from cystic fibrosis, compared to those without cystic fibrosis. A team of researchers recently investigated the molecular similarities between celiac disease and cystic fibrosis. Specifically, they set out to examine the role of mutations of the gene coding for cystic fibrosis transmembrane conductance regulator (CFTR), an anion channel pivotal for epithelial adaptation to cell‐autonomous or environmental stress. The study was led by Luigi Maiuri, Valeria Raia, and Guido Kroemer. They are variously affiliated with the San Raffaele Scientific Institute in Milan, Italy, the University of Naples Federico II in Italy, and the Paris Descartes University in France. Their research shows a connection between celiac disease and cystic fibrosis, and suggests that a compound developed for cystic fibrosis may also treat celiac disease. The results might bring us closer to a treatment for celiac disease. Failure of the cystic fibrosis transmembrane conductance regulator in cystic fibrosis patients triggers the accumulation of mucus in the patients’ lungs and intestine. By activating the immune system, the mechanism underlying CFTR malfunction causes several reactions in the lungs and other organs. These reactions are very similar to immune responses to gluten in celiac patients. Intrigued, Maiuri, Kroemer, and their colleagues took a closer look at the molecular underpinnings of these similarities. For people with celiac disease, eating gluten triggers the immune system to attack the mucus inside the small intestine. This immune attack presents as classic celiac symptoms, such as bloating, nausea, vomiting, diarrhea, and upset stomach. The team's findings appear in The EMBO Journal, and point to possible new therapies and treatments for celiac disease. The most promising part of the team's data indicate that CFTR potentiators, used to treat cystic fibrosis, may also be effective in treating celiac disease. With researchers revealing new connections between celiac and numerous other diseases, it's a very exciting time for celiac research. As researchers learn more about the connection between celiac disease and cystic fibrosis, look for new treatments for celiac disease in the not too distant future. Read more at: Medicalnewstoday.com

Celiac.com 06/23/2017 - Dr. Alessio Fasano from the University of Maryland's Celiac Research Center published a paper in Clinical and Developmental Immunology last month. It focused on a new drug developed by Dr. Fasano that has shown promising results in both animal and human trials. But is this the 'magic pill' that will cure celiac disease and gluten sensitivity? Let's take a look. The new drug, formerly called AT1001 but now renamed Larazotide Acetate, is a zonulin inhibitor. For those who have never heard the word 'zonulin', you might think it's a term from a science fiction movie. But zonulin is the protein that causes the 'gates' or openings between the cells making up the lining of the small intestine to open and close. These openings are called tight junctions and when zonulin gets excessive, a leaky gut ensues. Dr. Fasano has made great inroads to prove that a leaky gut is a problem that must be handled with gluten intolerance. The leaky gut perpetuates gluten's negative impact on other parts of the body. It can also initiate autoimmune disease. One key point to keep in mind is that 'leaky gut' occurs because molecules can pass between cells when they shouldn't. In addition, molecules can pass through cells which they also shouldn't. Unfortunately this new drug only impacts the former, not the latter. So, the drug Larazotide Acetate is a zonulin inhibitor. Now that we've reviewed what zonulin does as regards opening the gates, the purpose of inhibiting its action should make sense. How well does it work? In the recent human trials that were double-blind, randomized placebo-controlled (the best type of study, but I would expect no less from the stellar Dr. Fasano), a gluten exposure created a 70% increase in intestinal permeability (leaky gut) in 57% of the placebo group but only 28.6% of the patients receiving the drug (4 out of 14 patients) experienced such increased permeability. Further, gastrointestinal symptoms were significantly more frequent among patients of the placebo group as compared to the group that received the Larazotide. A pro-inflammatory substance known as interferon gamma was also evaluated. This is manufactured by the body when a specific foreign/toxic agent is recognized by the body's immune system. As expected, levels of interferon gamma increased in 4 out of 7 of the placebo patients (57%) but only 4 out of 14 larazotide patients (28.6%) saw any increase. The good news is that this drug seems well tolerated and it does reduce the leaky gut response that gluten ingestion normally creates. Further, it also reduces the percentage, by about half, of the production of interferon gamma. These are all excellent results. But, and it's unfortunately a very big 'but', we have a very long way to go before such a drug would be useful for your typical celiac or gluten sensitive patient. Will Dr. Fasano and his team be able to tweak this drug such that it functions at a higher level of efficacy? I certainly hope so, but let's analyze exactly what this drug does in its present state: The drug still resulted in almost 30% of the patients experiencing a 70% increase in permeability (leaky gut) – Not good. A highly pro-inflammatory (this means that it creates degenerative disease) substance known as interferon gamma was also produced in nearly 30% of the drug-consuming patients tested – Not good. Leakiness, or the passage of negative substances through cells is not affected by this drug – Not good. Of course on the plus side, over 70% of those tested DID have a very good result with apparently no untoward side effects – Very good. At what point is the efficacy high enough that you'd be willing to subject yourself to a possible reaction? Do realize that any gluten ingested increases your chance of disease, chief amongst them cancer and autoimmune disease. Is there a level of function of the drug that you would chance taking it? Is it 90%, 99%? Does any drug ever get that good? Well, as a big fan of Dr. Fasano's, I would say that if anyone can do it, he and his team can. But at the same time, I cannot help but think of all the other drugs I have encountered. As 'wonderful' as they sometimes seem initially, they almost always fall from grace when some horrible side effect is realized. Would I guinea pig my own health that I've fought so hard to regain? Would I recommend taking such a chance to my children just so that they could consume some white flour product? I don't think so. How about you? What do you think? If the drug were available right now at its efficacy of 71%, would you take it and hope you weren't in the 29% for whom it didn't work? I'd love to hear your thoughts. If you are wondering if you're gluten intolerant or know that you are but still aren't enjoying good health, consider calling us for a free health analysis: 408-733-0400. We are here to help! Our destination clinic sees patients from across the country and internationally so you do not need to live locally to receive assistance. To your good health! Reference: Alessio Fasano, Clinical and Developmental Immunology, Published online 2012 October 10. "Novel Therapeutic/Integrative Approaches for Celiac Disease and Dermatitis Herpetiformis."

Celiac.com 08/25/2017 - Japanese drug maker Daiichi Sankyo will pay $300 million to settle thousands of federal and state court lawsuits over its top-selling blood pressure drugs, Benicar, Benicar HCT, Azor and Tribenzor, according to the lead Plaintiffs' lawyers. The settlement was reached in the federal multi-district litigation (MDL) case titled In re: Benicar (Olmesartan) Products Liability Litigation, MDL 2606, pending in the U.S. District Court for the District of New Jersey, Camden Division. Overseeing the federal MDL litigation are the Honorable Judge Robert Kugler and the Honorable Magistrate Judge Joel Schneider, who handled the settlement negotiations. The agreement covers about 2,500 claims by individuals who claim severe and sometimes life-threatening gastrointestinal injuries after using medications containing the active ingredient olmesartan medoxomil (Benicar, Benicar HCT, Azor and Tribenzor). Numerous reports have tied Olmesartan to sprue-like enteropathy and changes in the intestinal tract that mimic those seen in celiac disease, and inhibit a person's ability to absorb nutrients. The parties reached the resolution as they maneuvered ahead of pre-trial hearings, and an expected trial in federal court. Christopher L. Coffin and Adam M. Slater, Co-Lead Counsel for the Plaintiffs, praised the settlement as an excellent outcome for the Plaintiffs. In a statement, Coffin said that they were "very pleased with the outcome of this hard-fought litigation. This is a gratifying resolution for thousands of patients who suffered severe gastrointestinal injuries while using these blood pressure medications." Under the settlement, former olmesartan users who have claims, and who meet certain criteria will be eligible for compensation. For more information go to OlmesartanProductLitigationSettlement.com.

Celiac.com 04/27/2017 - Celiac disease is associated with numerous chronic conditions, such as anemia and malabsorption of some critical vitamins. Changes in the gastrointestinal tract, rates of gastric emptying, and gastric pH are responsible for impaired vitamin and mineral absorption. Intestinal CYP3A4 levels may also be disrupted, which may have implications in first-pass metabolism for some drugs that are substrates for this drug metabolizing enzyme. This has led some researcher to investigate the potential impact of celiac disease on drug absorption. This would be of interest to pharmacists, since altered drug absorption can have pharmacokinetic consequences, along with the potential to impact overall drug therapy. A comprehensive review on this topic was published in 2013 by Tran et al. Another review was published in 2014. The review by Tran, et al., considered absorption studies in subjects with celiac disease, and the authors focused on a handful of drugs, including acetaminophen, aspirin, propranolol, levothyroxine, methyldopa, and some antibiotics. They reported that some reports show an altered gastrointestinal environment and sharp differences between drug absorption in patients with celiac disease, while other reports showed no absorption differences between those with and without the disease. The authors concluded that the drugs could potentially alter absorption in celiac patients, and that healthcare professionals should bear that in mind when starting drug therapy. The 2014 review of the potential impact of celiac disease on cardiovascular drug absorption considered many of the same medications previously explored by Tran et al, with a focus on cardiovascular agents. The authors warned that numerous cardiovascular drugs may alter absorption in celiac disease, but noted few published studies with strong, comprehensive data. The authors also stressed the need for more studies on celiac patients, as well as caution when initiating cardiovascular drug treatments. Available research indicates that patients with celiac disease can have altered absorption of many different drugs. Unfortunately, there still isn't much good data on altered drug absorption and disposition in celiac patients. More study will likely help illuminate the influence of celiac disease on drug disposition. The early evidence suggests that celiac disease may alter drug absorption, but studies don't yet tell us how much, or how often. The team is recommending that doctors and pharmacists consider possible absorption issues when prescribing drug treatments for people with celiac disease, and that they review the available literature on specific drugs, when possible. They also recommend increased monitoring for efficacy and adverse effects when beginning a new drug treatment regimen for celiac patients. Source: Pharmacy Times