Ocera Therapeutics, Inc (SAN DIEGO, California), a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat gastrointestinal (GI) and liver diseases, announced that it has completed patient enrollment of its double-blind, placebo-controlled phase III study in fistulizing Crohn's disease. The FHAST1 (Fistula Healing with AST-120) study is being conducted at sites in North America, Europe, and Israel.

Data from a double-blind, placebo-controlled Japanese study of AST-120 in Crohn's patients demonstrated that AST-120 significantly reduces draining perianal fistulas and improves PDAI and CDAI scores compared with placebo.

FHAST1 will determine the efficacy and safety of oral AST-120 administered for 8 weeks in 240 patients with mild-to-moderate Crohn's disease who suffer from perianal fistulas; approximately 30% of Crohn's patients suffer from draining fistulas. The primary efficacy endpoint of the study is the number of patients with at least a 50% reduction in the number of draining fistulas at weeks 4 and week 8 compared with baseline. Secondary endpoints include changes in Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI), two markers of disease severity and quality of life. Initial data from the trial will be available in the first quarter of 2008. Patients treated in the FHAST1 study who respond to therapy will be followed for 6 months.

AST-120 is an orally administered agent comprising highly absorbent, nanoporous, spherical carbon microspheres that absorb bile acids, toxins, and mediators of inflammation from the GI tract. The agent is marketed in Japan and Korea as a treatment to delay time to renal dialysis and reduce uremic symptoms in >200,000 patients with chronic renal failure. Ocera in-licensed AST-120 from Kureha Corp of Tokyo, Japan, and has rights to develop and commercialize the agent for the treatment of GI and liver indications in North America and Europe. In addition, Ocera has raised $26.5 million dollars in venture financing from Domain Associates, LLC; Sofinnova Ventures, Inc; and Thomas, McNerney & Partners.