Ocera Therapeutics, Inc. (OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced successful completion of a planned interim analysis of its STOP-HE study, a double-blind placebo-controlled study of OCR-002 in patients with acute hepatic encephalopathy (HE). The study's independent Data Monitoring Committee (DMC) reported that the trial is not futile and no drug-related safety signals have been observed in the study.
Based on the DMC's recommendation, Ocera will continue the STOP-HE study and will increase target enrollment from 140 patients to approximately 230 patients. The Company remains blinded to data reviewed by the DMC in the interim analysis.