Ocera tumbles 70% after phase 2 failure
- Disappointing results from the placebo-controlled STOP-HE Phase 2b study of Ocera Therapeutics' intravenous OCR-002 have shown a lack of statistical significance in hepatic encephalopathy.
- The outcomes showed a trend in improved clinical benefit, reducing the time to improvement (47 vs 64 hours) and complete resolution (87 vs 102 hours) of symptoms compared with placebo. Reduction in ammonia levels, a pre-specified exploratory endpoint, was statistically significant.
- Further analysis is planned, and Ocera's goal is still to move the drug into Phase 3.
Hepatic encephalopathy is a brain complication linked with liver cirrhosis and failure. Patients become confused and disoriented, their motor skills worsen and the disease can, in some cases, lead to coma and death.
The current approach to treatment, with an aim to reduce ammonia levels, is the antibiotic rifaximin or lactulose, a laxative. Without major competition, there is significant opportunity for a successful drug. Despite the results, the company retains its confidence in OCR-002, describing the outcomes as a key milestone for Ocera Therapeutics.
"The results confirmed that OCR-002 rapidly and safely lowered ammonia and showed a dose-related clinical benefit," said Linda Grais, CEO of Ocera. "The patients at the higher doses (15 and 20 grams) had faster clinical improvement and greater complete response rates compared to the patients on the lowest dose (10 grams) and those on placebo."
Ocera will carry out further analysis of the results, and use the findings to determine dose levels. It retains the goal of moving intravenous OCR-002 into Phase 3 development.
"Initial analysis shows that a higher percentage of patients respond as the dose of OCR-002 increases," said Stan Bukofzer, chief medical officer of Ocera. "This dose-response direction was also observed for the highly statistically significant ammonia reduction. Moreover, the safety profile shows no safety signal for OCR-002 compared to placebo. At the highest drug doses, there were favorable differences compared to placebo in the frequency of deaths and serious life threatening safety events."
- Ocera Therapeutics Statement
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