Data from Alvine’s ALV003 Phase 2A trial on celiac disease presented at DDW 2012

Published on May 23, 2012 at 12:10 AM · No Comments

Alvine Pharmaceuticals, Inc. today announced the presentation of data from a Phase 2A trial of its lead compound, ALV003, at the 2012 Digestive Diseases Week (DDW) meeting held in San Diego, California. The study results met the primary endpoint of demonstrating that oral ALV003, administered in the context of a gluten free diet (GFD), can diminish gluten-induced intestinal mucosal injury in well-controlled celiac disease patients. The company plans to initiate a Phase 2B trial later this year.    

The clinical study presented was a double-blind, placebo-controlled Phase 2A trial evaluating the efficacy and safety of ALV003 administered orally for six weeks. In the study, well-controlled, well-characterized adult celiac disease patients who had been maintained on a GFD for at least one year, were randomized to receive ALV003 or placebo daily for six weeks; patients were instructed to ingest 2g of gluten in the form of bread crumbs at the same meal as the study treatment. Study participants underwent small bowel biopsy prior to randomization and again, at the end of the six week challenge. The study met its primary endpoint, which was a clinically and statistically meaningful difference in intestinal mucosal morphometry (ratio of the villus height to crypt depth, or Vh:Cd) between the ALV003 and placebo treated groups over the six week study period. Secondary endpoints included change in intraepithelial lymphocyte (IEL) density, gastrointestinal symptoms as measured by Gastrointestinal Symptom Rating Scale (GSRS) scores, celiac serologies, safety and tolerability. The main study results were as follows:

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