Alvine Pharmaceuticals, Inc. has announced positive results from its Phase 2a clinical trial of ALV003, a therapeutic drug intended to minimize the small intestinal damage of gluten exposure among people with celiac disease.
In this phase of the trial, 41 adults with celiac disease and on a gluten-free diet were given a daily gluten challenge (2g of gluten in form of bread crumbs) for 6 weeks. During that time, participants received ALV300 or a placebo daily.
Researchers compared the results of small intestinal biopsies taken from each participant before and after the gluten challenge. Researchers also analyzed gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS) scores and blood test results, among other measures.
According to the researchers, participants who took ALV300 showed “significantly less” damage in their small intestine than those who took the placebo. The ALV300 group also had fewer symptoms according to GSRS scores and reported adverse events (i.e. diarrhea, abdominal pain, flatulence) less frequently than the placebo group. Researchers also reported that no significant changes were observed in the celiac serology tests among the ALV300 group.
While the drug is not intended to be a cure for celiac disease, it could be a safety net in cases of gluten exposure. Alvine Pharmaceuticals is now poised for the next steps in making this therapy a reality.
"Based on the results of this rigorously conducted trial, we believe that clinical proof-of-principle has been achieved. We are currently preparing for a Phase 2b trial of ALV003 in celiac disease patients targeted to begin in 2012," said Daniel Adelman, chief medical officer at Alvine Pharmaceuticals.
The study findings will be presented in a late breaking oral session at the 19th United European Gastroenterology Week (UEGW) in Stockholm on October 24. The full abstract (#OP050B) can currently be accessed on the UEGW website at www.uegw11.uegf.org.