Alvine Pharmaceuticals' drug compound, ALV003, has met the primary endpoint in diminishing gluten-induced intestinal mucosal injury in well-controlled celiac disease patients, in a Phase 2a trial.
ALV003 is an orally administered mixture of two recombinant gluten-specific proteases, a cysteine protease (EP-B2) and a prolyl endopeptidase (PREP) that degrades gluten into small fragments, which, in vitro, diminishes its immunogenicity.
In the double-blind, placebo-controlled Phase 2a trial, adult celiac disease patients who had been maintained on a gluten free diet (GFD) for at least one year, were randomised to receive ALV003 or placebo daily for six weeks.
The study's primary endpoint was a clinically 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, celiac serologies, safety and tolerability.
Patients treated with ALV003 had reduced small intestinal mucosal injury, as measured by Vh:Cd, and also showed favourable overall Gastrointestinal Symptom Rating Scale (GSRS) scores for indigestion and abdominal pain symptoms when compared to placebo-treated patients.
Alvine Pharmaceuticals senior vice president and chief medical officer Daniel Adelman said: "We are very encouraged by these results and are currently enrolling celiac disease patients in a study to evaluate and measure celiac-specific symptoms as a function of gluten exposure."
The company is planning to commence a Phase 2b trial for ALV003 later in 2012.
Celiac disease is an acquired autoimmune disorder that develops in genetically susceptible individuals after exposure to dietary gluten, the protein found in wheat, rye and barley that humans cannot fully digest.
Alvine Pharmaceuticals is a private, clinical-stage, specialty biopharmaceutical company focused on the development of biologics targeting autoimmune and inflammatory diseases, including celiac disease.