ARTICLE | Clinical News

Ocera's AST-120 meets Phase III endpoint

May 26, 2006 1:05 AM UTC

Ocera (San Diego, Calif.) said AST-120 met the primary endpoint of fistula improvement rate in a Phase III trial to treat fistulizing Crohn's disease, which was run by Kureha (Tokyo, Japan). In the double-blind, Japanese trial in 62 patients, 37% of those given AST-120 had a reduction of at least 50% from baseline in the number of draining fistulae compared with 10% for placebo (p=0.025). Ocera in-licensed North American and European rights to the compound to treat gastrointestinal and liver diseases from Kureha.

Ocera also started a double-blind, placebo-controlled international Phase III trial of AST-120 to treat patients with mild to moderate Crohn's disease who have fistulae. The primary endpoint is a reduction of at least 50% in the number of draining fistulae at weeks four and eight. The trial will enroll about 240 patients. Ocera expects data by the end of 2007. ...