Ocera Therapeutics licenses UCL liver failure research

UCL Business and biopharmaceutical company Ocera Therapeutics Inc have signed an exclusive worldwide licensing agreement for UCL-L1V - a compound that can be used to treat acute hepatic encephalopathy (AHE) based on international research led by Professor Rajiv Jalan and the Liver Failure Group at the Institute of Hepatology at UCL.

The research team led by Professor Jalan reported findings in Hepatology in February 2009 that the compound UCL-1V directly reduces blood levels of ammonia: a highly toxic chemical that builds up during attacks of AHE. The research also demonstrated that UCL-1V also led to a reduction in the pressure within in the cranium in models of AHE in acute liver failure and cirrhosis.

AHE is a reversible neuropsychiatric abnormality frequently seen as a complication of acute liver failure and cirrhosis. With severe liver impairment, toxic substances such as ammonia that are normally removed by the liver accumulate in the blood and impair the function of brain cells. Signs of AHE include impaired cognition, uncontrolled movements and decreased levels of consciousness leading to coma.

Cirrhosis, which can cause AHE, occurs due to a variety of causes such as hepatitis B and C infection, alcohol, and fatty liver associated with obesity and diabetes. Cirrhosis is estimated to affect one percent of the world population and is thought to be responsible for over 1.4 million deaths annually.

Acute liver failure is a life-threatening condition in otherwise healthy patients and is most commonly caused by an overdose of paracetamol. Other causes include reactions to other drugs, herbs, or acute hepatitis. AHE is one of the common complications of cirrhosis and acute liver failure. Globally, around 40 percent of all liver cirrhosis patients will suffer from some degree of AHE.

Ocera will develop the licensed compound as the second compound in its portfolio pipeline (its pipeline of products related to AHE), and will refer to it as OCR-002. OCR-002 will be a novel injectable treatment for AHE in patients with advanced liver cirrhosis and acute liver failure.

Clinical trials in patients with AHE due to cirrhosis and acute liver failure will be carried out at University College Hospital as well as other centres in 2009 under funding from the Medical Research Council. Ocera is planning to file an investigational new drug application process in late 2009 and and US trials will begin in early 2010.

"There is a significant unmet clinical need to treat hepatic encephalopathy which affects 40-60 percent of patients with established liver disease," said Professor Jalan. "Unlike UCL-L1V, none of the currently available treatments directly lowers circulating levels of ammonia. The partnership with Ocera is a significant step towards bringing this potentially lifesaving discovery to patients."

Mr. Cengiz Tarhan, Managing Director of UCL Business said, "This is a significant deal for UCL Business. I am delighted that Ocera is licensing the technology from us. In Ocera, we have found the perfect development and commercialisation partner. They specialise in liver and gastrointestinal drug development and have a demonstrated track record. I am excited to enter this relationship to tap into their extensive experience to bring this technology to market."

"We are pleased to have licensed this breakthrough treatment for patients hospitalised with acute hepatic encephalopathy," said Dr. Laurent Fischer, President and CEO of Ocera Therapeutics. "By directly reducing blood levels of ammonia, OCR-002 has the potential not only to improve symptoms of encephalopathy but may also help to reverse this life-threatening condition and reduce healthcare costs by minimising a patient's time in intensive care."

UCL Context

The Liver Failure Group, headed by Professor Rajiv Jalan, is based at the Institute of Hepatology at UCL. The research conducted by the group covers many aspects of acute and chronic liver disease. The focus of the Liver Failure Group is to better understand the mechanisms of liver failure and use this knowledge to develop disease biomarkers and design novel therapeutic strategies. The group includes clinicians and scientists.

UCL Business PLC (UCLB) is responsible for commercialising research across all disciplines generated from within UCL and associated organisations. It is primarily responsible for protecting inventions and transacting commercial activity including options, licences and collaborative commercial research. UCLB also has responsibility for creating and spinning-out companies from UCL. UCLB is wholly-owned by UCL and operates as an independent company with its own board of directors.

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