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Celiac Disease

October 17, 2011

Alvine Pharmaceuticals released results from a phase IIa trial of ALV003 for celiac disease. This double-blind, placebo-controlled trial enrolled 41 adult subjects who were randomized to receive ALV003 or placebo daily for six weeks at the time of ingestion of 2g of gluten. The subjects underwent a small bowel biopsy at the beginning of the trial and after being given the daily gluten challenge for six weeks. The primary endpoint was intestinal villus morphometry measured at baseline and at six weeks. Biopsy results from 34 evaluable subjects showed that there was significantly less small intestinal mucosal injury in subjects treated with ALV003 than those treated with placebo (p≡0.013). In addition, the data showed statistically significant differences in changes in intraepithelial lymphocyte density and both alpha/beta and gamma/delta T-lymphocyte subsets.

November 3, 2008

Alvine issued positive results from a phase I trial of ALV003 for the treatment of celiac disease. This single-blind, placebo controlled, dose-escalation clinical trial enrolled 36 subjects, both healthy and with Celiac disease, in the US. The subjects received placebo or a single dose of ALV003 (100 mg, 300 mg, 900 mg, or 1800 mg) following a test meal containing 1 gram of gluten. Results demonstrated that single doses of up to 1,800 mg of ALV003 were safe and tolerable in healthy subjects. Doses at the 300 mg level achieved up to a 96% reduction of gluten in a meal in the stomach at 30 minutes, and were well tolerated by patients with celiac disease. In addition, doses as low as 100 mg were shown to be biologically active in degrading gluten in the stomach. Based on these results, Alvine plans to initiate phase I/IIa multi-dose trials in early 2009.

November 20, 2006

Alba released positive data from a phase Ib trial of AT-1001 for the treatment of Celiac Disease (CD). This double blind, placebo controlled trial was designed to study the safety, tolerability and effectiveness of single doses of oral AT-1001 in adult CD subjects in remission that were challenged with a large dose of gluten. The primary endpoint was intestinal permeability. Treatment was safe and well tolerated, with no serious adverse events reported. Following the 2.5 gram gluten challenge, intestinal barrier function was maintained in the subjects receiving AT-1001 while a significant increase in intestinal permeability was observed in the placebo group. In addition, symptoms of acute gluten toxicity were inhibited in the AT-1001 arm when compared to placebo. AT-1001 plasma concentrations were immeasurable (< 0.5 ng/ml), indicating little to no systemic absorption when administered orally. Alba is currently investigating AT-1001 in a phase II trial.