Alvine Reports Positive Results From Phase I Celiac Disease Trial
Alvine Pharmaceuticals, a biopharmaceutical company, has announced proof of concept in a Phase I trial of ALV003, an oral protease therapy in development to detoxify gluten, intended for use by patients with celiac disease.
The trial results confirmed that single doses of up to 1,800mg of ALV003 were safe and tolerable in healthy volunteers. Doses at the 300mg level achieved up to a 96% reduction of gluten in a meal in the stomach at 30 minutes, and were well tolerated by patients with celiac disease.
In addition, doses as low as 100mg were shown to be biologically active in degrading gluten in the stomach. Based on these results, Alvine plans to initiate Phase I/IIa multidose trials in early 2009.
Alvine also reported encouraging results from a previous study in patients with celiac disease. The study demonstrated that patients with celiac disease who ingested gluten pre-treated with ALV003 showed elimination of peripheral gluten specific reactive T cells as measured by ELISpot responses.
The study, conducted at the Alfred Hospital and Burnet Institute in Melbourne, Australia, suggests that a gluten specific ELISpot response may be a useful test for assessing the effectiveness of therapeutics in subjects with celiac disease.
Peter Green, professor of clinical medicine at Columbia University, said: “Results from these studies support the use of ALV003 as a drug to be taken with meals to address unintentional gluten exposure. In addition, the ELISpot study provides evidence that treatment of gluten with ALV003 may result in a reduction in the immune response to gluten in patients with celiac disease. These results provide a strong rationale to advance the clinical development of this compound as a treatment for celiac disease.”