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Ocera Therapeutics starts patient enrollment in Phase IIb trial to treat HE patients

Published on 14 January 2014

 

Ocera Therapeutics last week announced the admission of its first patient in its multi-centre phase 2b, OCR-002 clinical trials. The study, which is expected to be completed by early 2015, will evaluate the efficiency and safety of OCR-002 in patients with an acute hepatic encephalopathy (HE).

HE is a serious complication of patients with liver cirrhosis, acute liver failure and acute liver injury. When the liver is no longer able to function normally there is an accumulation of ammonia in the blood, due to the damage of usual metabolic pathways. This change of ammonia concentration in the blood can lead to the decline of neurocognitive function which leads to impaired cognition, lethargy, disorientation and a decreased level of consciousness; brain swelling from HE can result in a coma and death.

Leading to approximately 150 000 hospitalisations per year in the US, the best treatment options for HE are still of less than the highest standard. OCR-002 will be administered as an intravenous infusion; the novel molecule is proposed to rapidly reduce the concentration of ammonia in the blood and has been granted orphan drug designation by the US Food and Drug Administration (FDA).

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.

Commenting on this recent development, Mr Cengiz Tarhan, Managing Director of UCLB said, “We are delighted that Ocera are commencing the Phase 2b development of OCR-002 to the critical Proof of Concept in man.  This will bring this novel UCL therapeutic one step closer to regulatory approval and ultimately patient benefit. Ocera continue to have the full support of UCLB throughout the development of OCR-002.”

 

About Ocera Therapeutics

Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate). OCR-002 is an ammonia scavenger which has been granted Orphan Disease and Fast Track status from the FDA to treat hyperammonemia and associated hepatic encephalopathy in patients with liver cirrhosis, acute liver failure and acute liver injury. For additional information, please see www.ocerainc.com.

 

About UCLB

UCLB is a leading technology transfer company that supports and commercialises 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. It invests directly in development projects to maximise the potential of the research and manages the commercialisation process of technologies from the laboratory to market.

UCLB supports UCL’s Grand Challenges of increasing UCL’s positive impact on and contribution to Global Health, Sustainable Cities, Intercultural Interaction and Human Wellbeing.

For further information, please visit www.uclb.com

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