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Showing results for tags 'therapeutics'.
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Celiac.com 10/11/2022 - Enzymes that can break down gluten in the stomach before it gets to the gut are a potentially important therapy tool for people with celiac disease. In people with celiac disease, the digestion of gluten creates peptides, including the strongly immunogenic proline-rich 33-mer from wheat α-gliadin, that trigger auto-immune reactions in the gut, along with associated villi damage, when untreated. Having a therapy that could reduce the abundance of the 33-mer in the small intestine could be very helpful to many people with celiac disease. Neprosin is the latest candidate. A team of researchers recently set out to test a glutamate-class prolyl-endopeptidase for celiac disease therapy. The research team included Laura del Amo-Maestro, Soraia R. Mendes, Arturo Rodríguez-Banqueri, Laura Garzon-Flores, Marina Girbal, María José Rodríguez-Lagunas, Tibisay Guevara, Àngels Franch, Francisco J. Pérez-Cano, Ulrich Eckhard & F. Xavier Gomis-Rüth. They are variously affiliated with the Proteolysis Laboratory at the Department of Structural Biology, Molecular Biology Institute of Barcelona (CSIC), Barcelona Science Park in Barcelona, Catalonia, Spain; the Section of Physiology; Department of Biochemistry and Physiology; Faculty of Pharmacy and Food Science, University of Barcelona, Barcelona, Catalonia, Spain; and the Research Institute of Nutrition and Food Safety (INSA-UB), University of Barcelona in Barcelona, Catalonia, Spain. Neprosin from the pitcher plant is a reported prolyl endopeptidase. As part of their effort, the team produced recombinant neprosin, along with several mutants, and revealed that full-length neprosin is a zymogen, which is self-activated at gastric pH by the release of an all-β pro-domain via a pH-switch mechanism featuring a lysine plug. The team describes the catalytic domain, in which the action occurs, as an atypical 7+8-stranded β-sandwich, with an extensive active-site cleft holding an unprecedented pair of catalytic glutamates. The researchers found that neprosin quickly and effectively breaks down both gliadin and the 33-mer in vitro under gastric conditions. The action can be reversibly inactivated above pH 5. Moreover, administering gliadin and the neprosin zymogen together at the ratio 500:1 reduces the abundance of the 33-mer in the small intestine of mice by up to 90%. A 90% reduction in the 33-mer means that a substantial reduction in the ability of the protein to trigger an immune response in people with celiac disease. Neprosin therefore represents a family of eukaryotic glutamate endopeptidases that meets the parameters for an effective therapeutic glutenase. The development of effective therapeutic glutenase products remains a top priority for many researchers, with the potential to benefit huge numbers of people with celiac disease, many of whom are subject to accidental gluten ingestion on a regular basis. Read more in Nature Communications volume 13, Article number: 4446 (2022)- 6 comments
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Celiac.com 02/09/2014 - Anyone with celiac disease knows how important it is to read the labels on food and beverage products. This is also very important when it comes to supplements. Celiac disease affects how the body absorbs vitamins and minerals, so choosing a supplement to replace those lost is essential. It is also wise to consider a supplement that provides other benefits such as digestive enzymes, antioxidants, and probiotics. If you can get one gluten-free supplement that does all this – you've hit the jackpot and I think this is the case with Gluten Free Therapeutics' new Celi-Vites Body Health capsules. In addition to being a great multivitamin, this supplement contains zinc, selenium, copper, manganese, chromium, and molybdenum in a chelated form. Mineral supplements provided as chelated are said to have dramatically improved absorption rates over mineral supplements provided as simple "mineral salts" like zinc chloride. Celivites also provides digestive support and antioxidants. Additionally, Celi-Vites contains a proprietary blend of phytonutrients not currently available in any other supplement. Phytonutrients are plant-derived compounds associated with positive health effects. I tried them and really liked them. If you want just one supplement because you don't like taking dozens of different pills a day. -
Fish oil supplements provide well-established health benefits, but they are especially beneficial for celiacs because they aid in the recovery of fat levels and reduce intestinal inflammation. Eagle Therapeutics' CeliAct Fish Oil is tailored specifically to the needs of celiacs: taking CeliAct alone is great, but you really need that extra fat to heal your intestines. The capsules are of a decent size, but I can easily swallow two at once. I have not taken other fish oil supplements, but I know that many who do experience the dreaded “fish burp”. I am happy to say that I still have not experienced this phenomenon, but I have noticed feeling generally more focused. Placebo effect or not, I'm going to keep taking them. For more information, visit their site. Note: Articles that appear in the "Gluten-Free Food & Specialty Product Companies" section of this site are paid advertisements. For more information about this see our Advertising Page. -
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 03/14/2006 - Alba Therapeutics Corporation announced today successful completion of Phase Ib proof-of-concept studies for its lead compound, AT1001. In a 21-patient cohort of celiac disease sufferers, the oral administration of AT1001 versus placebo control induced a significantly positive result in the trials primary target endpoint. "We anticipated a strong signal, however, the magnitude of the response surpassed our expectations," stated Blake Paterson, M.D., President and CEO of Alba. "We are particularly excited, as to the best of our knowledge this is the first demonstration of a desired and systemic immunological effect resulting from a physiological event at a mucosal surface." AT1001 is an antagonist to the zonulin system -- a signaling pathway discovered by Alessio Fasano, M.D., Professor of Pediatrics, Medicine and Physiology at the University of Maryland School of Medicine, and the basis of Albas extensive intellectual property portfolio. About Zonulin Zonulin is a 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. Zonulin appears to be involved in many diseases 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 autoimmune diseases. About Celiac Disease 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. According to the National Institutes of Health, celiac disease affects approximately 3 million Americans, although the diagnosis is rarely made. 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. 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 other auto-immune illnesses. Contact: Heather Bakalyar, 410-522-8708 x1106
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