Ocera announces top-line results for phase 2b study in hepatic encephalopathy
Ocera Therapeutics, Inc. announces top-line results from its exploratory STOP-HE Phase 2b Study evaluating the efficacy, safety and tolerability of intravenously administered Ornithine Phenylacetate (OCR-002) in hospitalized patients with Hepatic Encephalopathy (HE).
“This is a key milestone for Ocera: the results confirmed that OCR-002 rapidly and safely lowered ammonia and showed a dose-related clinical benefit,” said Linda Grais, M.D., Chief Executive Officer of Ocera. “The patients at the higher doses had faster clinical improvement and greater complete response rates compared to the patients on the lowest dose and those on placebo. These findings will be integral in determining dose levels for future studies. We want to thank the patients and their families, caregivers and investigators for their support and participation in STOP-HE.“.
Ocera Therapeutics licensed exclusive worldwide rights for the development and commercialisation of OCR-002 from UCL Business (UCLB), in April 2009. UCLB initially supported the HE project with proof of concept funds and a strategic investment from its own investment funds to perform studies to support a clinical trial.
Read the full findings: http://ir.ocerainc.com/releasedetail.cfm?ReleaseID=1009540
About UCL Business PLC
UCL Business PLC (UCLB) is a leading technology commericalisation company that supports the research and innovations arising from UCL, one of the UK’s top research-led universities. UCLB has a successful track record and a strong reputation for identifying and protecting promising new technologies and innovations from UCL academics. UCLB has a strong track record in commercialising medical technologies and provides technology transfer services to UCL’s associated hospitals; University College London Hospitals, Moorfields Eye Hospital, Great Ormond Street Hospital for Children and the Royal Free London Hospital. It invests directly in development projects to maximise the potential of the research and manages the commercialisation process of technologies from laboratory to market.
Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate) in both intravenous and oral formulations. OCR-002 is an ammonia scavenger and has been granted orphan drug designation and Fast Track status by the U.S. Food and Drug Administration (FDA) for the treatment of hyperammonemia and resultant hepatic encephalopathy (HE) in patients with acute liver failure and acute-on-chronic liver disease.
Ocera’s HE clinical development efforts also include a recently completed Phase 1 clinical trial in patients with cirrhosis as a potential chronic use option to maintain remission of HE. The Company expects to initiate a multi-dose Phase 2a study, also in cirrhotic patients, in the first half of 2017. For additional information, please see www.ocerainc.com.
About STOP-HE Study Design
STOP-HE was a placebo-controlled, randomized, double-blind clinical trial designed to evaluate the safety, pharmacokinetics and efficacy of intravenously-administered OCR-002 in resolving neurocognitive symptoms of acute HE in 231 hospitalized patients with liver cirrhosis and elevated serum ammonia (hyperammonemia). Either OCR-002 or placebo was administered to patients intravenously as a continuous infusion for up to five days along with standard of care. The OCR-002 arm was dosed with 10, 15 or 20 grams over 24 hours based on the patient’s degree of liver impairment and modeling of OCR-002 metabolism, in addition to safety considerations in this high risk patient population.
About Hepatic Encephalopathy
Hepatic encephalopathy is a debilitating and progressive complication of liver cirrhosis or liver failure, marked by increasing ammonia levels, mental changes including confusion, impaired motor skills, disorientation, and in its more severe form, stupor, coma and even death. The condition is categorized as either covert or overt depending on the degree of neurocognitive impairment, with overt HE (OHE) typically precipitating the need for hospitalization. Patients frequently cycle from remission to recurrence following an initial overt episode. The number of OHE episodes appears to be directly linked to persistent neurological impairment and seems to be cumulative; thus the need to manage HE patients is vital. It is estimated that HE-related hospitalization costs exceed $7 billion1 annually in the U.S. alone.
1 Clinical Gastroenterology and Hepatology 2012; 10:1034-1041