Alvine’s Lead Drug Candidate: ALV003
Alvine Pharmaceuticals is developing ALV003, a mixture of two gluten-specific recombinant proteases, to be administered as an adjunct to an attempted gluten-free diet for the potential treatment of celiac disease.
Alvine successfully completed two separate ALV003 phase 1 pharmacokinetic and pharmacodynamic studies. These studies enrolled healthy volunteers as well as celiac disase patients. ALV003 was pharmacokinetically stable and had pharmacodynamic effects in the human stomach. Data were presented at the 2009 DDW (Digestive Diseases Week) Conference in Chicago, IL.
A phase 2a study conducted in Finland demonstrated that ALV003 administered daily for 6 weeks to celiac patients, well controlled on a GFD, could attenuate small intestinal mucosal injury induced by a daily gluten challenge under the controlled conditions of the study. Data were presented at the 2011 UEGW (United European Gastroenterology Week) Conference in Stockholm, Sweden, and at the 2012 DDW (Digestive Diseases Week) Conference in San Diego, CA.
A double-blind placebo-controlled, randomized, dose-ranging phase 2b study is underway in celiac disease patients maintained on a gluten-free diet; symptomatic patients with evidence of on-going mucosal inflammation will be randomized to either placebo or active treatments. Endpoints will include changes in mucosal morphometry, symptoms and celiac serologies.