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: