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Celiac.com 09/10/2007 - A study published recently in the journal of Alimentary Pharmacology and Therapeutics shows that the paracellular permeability inhibitor AT-1001 effectively reduces intestinal barrier dysfunction, proinflammatory cytokine production, and gastrointestinal symptoms in people who have celiac disease. At present, a lifetime devoted to following a strict gluten-free diet is the backbone of current treatment for celiac disease. However, as researchers have come to know more about celiac disease, they’re insights are leading to developments that offer more effective prognosis and treatment of the disease. One of those promising new approaches involves treating celiac patients with doses of AT-1001, a paracellular permeability inhibitor that is structurally derived from a protein secreted by Vibrio cholerae. Recently, a team of medical researchers set out to assess the safety and tolerability of 12 mg doses of AT-1001 in people with celiac disease who submitted to acute gluten exposure. For the in-patient, double-blind, randomized placebo-controlled safety study, researchers looked at twenty men and women with celiac disease and measured intestinal permeability, through fractional excretions of lactulose and mannitol, as an exploratory measure of the efficacy of AT-1001 in treating celiac disease. The test subjects were men and women with age ranging from 18 to 59 years old. Each was pre-screened and referred by a gastroenterologist. Each had positive biopsy and antibody screens that indicated celiac disease. Each had also been on a gluten-free diet at least six months, was not known to be IgA deficient, and presented with anti-tTG titres of <10 EU at enrollment. Study shows safety and tolerability of 12 mg doses of AT-1001 in celiac disease In the placebo group, acute gluten exposure brought an observable 70% increase in intestinal permeability, compared to no change at all in the AT-1001 group. Four of seven patients (57%) of the placebo group showed increased levels of Interferon-gamma levels, but in the AT-1001 group only four of 14 patients (29%) showed such increases. Also, the placebo group showed gastrointestinal symptoms more frequently than the AT-1001 group (P = 0.018). From the results, the researchers concluded that AT-1001 is well tolerated and appears to reduce intestinal barrier dysfunction, pro-inflammatory cytokine production, and gastrointestinal symptoms in celiac patients subjected to gluten exposure. Aliment Pharmacol Ther 26, 757-766 health writer who lives in San Francisco and is a frequent author of articles for Celiac.com.
Celiac.com 05/27/2008 - People with celiac disease know all too well that the only effective treatment at present is faithfully following a gluten-free diet. There’s been a lot of talk about various therapies and enzyme treatments that would allow people with celiac disease to return to a normal diet. Talk to anyone who suffers from celiac disease and they’ll likely have a personal horror story about a time when they had an unhappy episode of cross-contamination. So, the idea of a drug that would prevent such symptoms is appealing, and the goal, desirable. The chief cause of recurring symptoms in celiac disease is accidental gluten exposure, usually through cross-contamination. Cross-contamination doesn’t always mean food. Gluten is a common ingredient in many medicines and vitamins, and exposure in celiacs can cause diarrhea, weight loss, abdominal pain, anemia and oral ulcerations in the short-term, and myriad other problems in the long-run. The drug AT-1001 is a good example of how the realities are playing out on the front-lines of science. AT-1001 is an enzyme therapy that has promised some degree of protection from gluten exposure in people with celiac disease. A team of researches recently set out to assess the effectiveness of AT-1001 in preventing gluten from crossing the gut barrier by reversing the defective barrier mechanism. This required evaluating intestinal permeability between those exposed to gluten after taking AT-1001, those exposed without AT-1001, and control groups. The of intestinal function is done by gauging the absorption rates of various sugars. Early testing of AT-1001 showed some progress and a significant rate of protection of celiac patients exposed to wheat proteins. The research team looked at 86 subjects with celiac disease. The patients were divided into three groups. The first group was given placebo AT-1011 and challenged with gluten, the second group was given either active or placebo AT-1001, while the third group was given gluten and active AT-1001. After the first week, all subjects showed improvement, possibly due to closer adherence to a gluten-free diet. At three weeks, those given AT-1001 showed substantial improvement over the group given gluten and placebo AT-1001, including reduced intestinal permeability and fewer symptoms of gluten toxicity. The problem is that while AT-1001 shows a degree of promise, the results are so far underwhelming. The research team noted that the degree of improvement did not match the primary study. The results are, however, strong enough to encourage researchers to conduct a larger trial of AT-1001, which is currently underway. It’s important to remember that celiac disease is an immune disorder and no immune disorder has ever been fully cured. So, the idea of people with celiac disease being able to take a pill and head out for a night of pizza and beer without the standard celiac-related reactions is far-fetched at best. At best, such drugs would likely help to prevent cross-contamination, rather than conveying immunity to gluten proteins. Until then, stay tuned…best of luck with the gluten-free diet! Presented by Dr. Leffler at the 2009 Digestive Disease Week on Tuesday, May 20 at 10:45 a.m. Pacific Time in room 10, San Diego Convention Center.
Celiac.com 05/08/2007 - Announces Plans for Advancing AT-1001 into Later Stage Clinical Trials Alba Therapeutics Corporation today announced preliminary results from its Phase IIa clinical trial for AT-1001 in subjects with Celiac Disease (celiac disease), an autoimmune disease affecting over 3 million people in the United States. Albas study, the first Phase IIa trial in celiac disease and the first to assess dosing requirements for AT-1001 in celiac disease, was designed to evaluate the safety, tolerability and efficacy of multiple doses of AT-1001 in celiac disease subjects during a 2-week gluten challenge. The randomized, double-blind, placebo-controlled clinical trial enrolled 86 patients who were confirmed biopsy positive for celiac disease and in compliance with a gluten-free diet for at least six months prior to enrollment. Patients were randomized into seven drug-treated and placebo groups and challenged three times a day with gluten during a 14-day period. Four doses of the enteric coated oral formulation of AT-1001, all less than 10 mg, were given prior to each gluten challenge. Study endpoints included intestinal permeability (IP) -- a marker of disease state in celiac disease -- as well as patient symptoms and outcomes, measured by two validated tests of gastrointestinal disease outcome: the Gastrointestinal Symptoms Rating Scale (GSRS) and the Psychological General Well-Being Index (PGWBI). Preliminary analysis revealed the following: -- At day 14, IP, as measured by the change in urinary lactulose-to- mannitol (LA/MA) ratio, exhibited a dose dependent response. On day 21, one week after the final drug dosing and gluten challenge, the dose dependent trend continued to statistically significant levels. -- The GSRS and PGWBI provided additional efficacy signals that further support the IP observations. Patients on the AT-1001 drug arms performed better than those on the gluten/placebo arm. Analyses demonstrated that several symptoms and outcomes improved at statistically significant levels. -- Safety and tolerability of multiple oral doses of AT-1001 in the patient population was demonstrated. There were no Severe Adverse Events and all Adverse Events were reported as mild or moderate. "We are very encouraged by the preliminary data and look forward to applying the extensive knowledge gained in this Phase IIa exploratory clinical trial to a larger, highly powered Phase IIb gluten challenge study later this year" said Blake Paterson, M.D., Chief Executive Officer of Alba Therapeutics. Using the highly complex and ambitious seven arm study design for the Phase IIa trial, we repeated the proof of concept from the Phase Ib study, showed a statistically significant effect across a variety of measures and are well prepared to move the celiac program forward." Based on these results, Alba will advance AT-1001 into a Phase IIb clinical study in celiac disease subjects during the third quarter of 2007. The Phase IIb study, to be performed in multiple centers in the United States and Canada, will assess the efficacy of AT-1001 utilizing multiple endpoints, including a composite index of disease activity. The first patient is expected to be enrolled into this study in the third quarter of 2007, and the study should conclude in early 2008. About Celiac Disease Celiac Disease is a T-cell mediated autoimmune disease that occurs in genetically susceptible individuals and is characterized by small intestinal inflammation, injury and intolerance to gluten. According to the National Institutes of Health, celiac disease affects approximately 3 million Americans. The only current treatment for celiac disease is complete elimination of gluten from the diet, which results in remission for some patients. About Alba Alba Therapeutics Corporation is a privately held biopharmaceutical company based in Baltimore, Maryland dedicated to the development and commercialization of disease modifying therapeutics to treat autoimmune and inflammatory diseases based upon the regulation of tight junctions. Albas lead compound, AT-1001, is targeted towards the treatment of Celiac Disease, Inflammatory Bowel Disease and Type 1 Diabetes Contact: Stuart Sedlack, SVP, Corporate Development Phone: +1-410-319-0780
Celiac.com 10/28/2005 - Alba Therapeutics Corporation (Alba) today announced successful completion of its first Phase I trial for the drug candidate AT-1001, and that the FDA has granted Fast Track designation to AT-1001 for treatment of celiac disease. We are pleased to have concluded our first human study of oral AT-1001 and delighted that the FDA has granted fast track status to AT-1001. These two events are important additional milestones in our efforts to help those suffering from celiac disease, a disease for which there is no effective treatment, said Blake Paterson, MD, President and CEO of Alba. Alba plans to begin a proof of concept study demonstrating efficacy of AT-1001 in celiac patients within the next few months. Fast track process is designed to facilitate development and expedite the review of new drugs with the potential to address significant unmet medical needs for the treatment of serious or life-threatening conditions. Potential fast track benefits include FDA input into development, submitting new drug applications in sections rather than all at once and the option of requesting Accelerated Approval. About Celiac Disease Celiac disease is a T-cell mediated auto-immune disease that occurs in genetically susceptible individuals and is characterized by small intestinal inflammation, injury and intolerance to gluten. Gluten is a mixture of proteins found in common food grains such as wheat, rye and barley. According to the NIH, celiac disease affects approximately 3 million Americans, although the diagnosis is rarely made. The only treatment for celiac disease is complete elimination of gluten from the diet, which results in remission for some patients. About Zonulin Zonulin is an endogenous signaling protein that transiently and reversibly opens the tight junctions (tj) between the cells of epithelial and endothelial tissues such as the intestinal mucosa, blood brain barrier and pulmonary epithelia. Discovered by Alba co-founder Dr. Alessio Fasano, zonulin appears to be involved in many disease states in which leakage occurs via paracellular transport across epithelial and endothelial tight junctions (tj), and thus may play an important potential role in the treatment of auto-immune diseases. About Alba Alba Therapeutics Corporation is a privately held biopharmaceutical company based in Baltimore, Maryland. Alba is dedicated to commercializing disease-modifying therapeutics and drug delivery adjuvants based on the zonulin pathway. Albas lead molecule, AT-1001, is targeted towards the treatment of Celiac Disease and Type 1 Diabetes. Contact: Dr. Blake Paterson Alba Therapeutics Corporation 410-522-8708