Ocera completes interim analysis of OCR-002 in Phase 2b STOP-HE study for the treatment of acute hepatic encephalopathy
Posted: 2 April 2015 |
Ocera has announced successful completion of a planned interim analysis of its OCR-002 STOP-HE study in patients with acute HE…
![OCR-002](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/eu-disease-lens-research.jpg)
![OCR-002](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/eu-disease-lens-research.jpg)
Ocera Therapeutics has 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.
OCR-002 may help patients with HE recover more rapidly from acute episode
“We are encouraged that these early data suggest a promising treatment effect with OCR-002 and a reduction in time to recovery for patients with acute hepatic encephalopathy,” said Linda S. Grais, M.D., Chief Executive Officer of Ocera. “While the new enrollment target will extend our timelines, we believe that this will enhance the likelihood of achieving a positive result at the end of the study. Treatment options for these severely ill patients are sub-optimal. We believe OCR-002 may help these patients recover more rapidly from acute episodes of HE, as well as provide pharmacoeconomic benefit to hospitals, payors and the healthcare system. With the new enrollment target, we anticipate completing this trial in the second half of 2016.”
HE is a serious, rare, progressive and episodic complication of liver cirrhosis, or liver failure, marked by mental changes including confusion, impaired motor skills, disorientation in time and space, and in its more severe form, stupor, coma and even death.
“This positive recommendation is important for the advancement of newer therapies for seriously ill HE patients who are not responding to current standard of care,” commented Dr Jasmohan Bajaj, a STOP-HE study investigator. “HE in the acute care setting remains a challenging clinical condition. OCR-002 is a novel, promising therapeutic option for HE and we look forward to the speedy completion of this trial.”
For more information about Ocera Therapeutics, please visit www.ocerainc.com.