Ocera starts phase 1 clinical trial of OCR-002 oral drug candidate

These formulations will be compared against an immediate release oral solution of drug candidate OCR-002 and ammonia-lowering agent glycerol phenylbutrate (RAVICTI®), a pre-pro drug of phenylacetate, a component of OCR-002. The Phase 1 trial is an open-label, five-treatment, five-period crossover study expected to be completed by the end of 2015.

Ocera president and CEO Linda Grais said: "We are very excited to have initiated human testing of our prototype oral formulations of OCR-002.

"These preliminary formulations contain the same active ingredient, ornithine phenylacetate, currently being evaluated in an intravenous (IV) dosage form in our STOP-HE Phase 2b study. OCR-002 is a novel molecule which functions as an ammonia scavenger and has the potential to treat and prevent a serious neurocognitive disorder, hepatic encephalopathy (HE) related to elevated ammonia levels that can occur in patients with advanced cirrhosis or acute liver failure.

"OCR-002 is, to our knowledge, the only ammonia scavenger in clinical development for the treatment and now prevention of HE. Over 100 patients have been enrolled in our STOP-HE Phase 2b trial in acute HE, and with the initiation of this Phase 1 trial, we are one step closer to realizing our vision of providing continuity of care to HE patients."

In conjunction with the announcement of the advancement in the company’s clinical development program, Ocera today further announced that Mark Coffin, Ph.D. has joined the company as Vice President of Pharmaceutical Development and Manufacturing, and Renu Jain, Ph.D. has joined as Vice President of Clinical Development. Both Coffin and Jain will be located at the Research Triangle Park office in Durham, N.C.

"Mark is a highly experienced pharmaceutical professional and we couldn’t be more pleased to have someone with his knowledge and depth of expertise joining the team," said Dr. Grais. "He will be instrumental in designing and executing the chemical and pharmaceutical development strategies for the company’s drug candidates and we believe he will be a tremendous asset as we advance the oral formulation of OCR-002."

Dr. Coffin comes to Ocera after approximately 25 years of experience at GlaxoSmithKline, where he held numerous positions of increasing responsibility, most recently serving as the U.S. Head of Process Robustness and 2nd Generation Drug Product. During his tenure at GSK, he was responsible for the development and global manufacturing of API and finished drugs and was involved in bringing more than 6 products to market. He has extensive experience in Research & Development, Process development, cGMP manufacturing, Analytical development and Quality systems. He received a Ph.D. in Pharmaceutics from The University of Texas at Austin and a B.S. in Pharmacy from Purdue University.

"We are also pleased to welcome Renu to the clinical team, and in doing so, we’ve expanded our capacity to execute on the strategic and tactical elements of our clinical development activities," said Dr. Grais. "Her extensive, international hands-on clinical development experience, particularly with rare and orphan diseases, makes her ideally suited to lead our clinical programs for OCR-002."

Dr. Jain joined Ocera from Grifols Therapeutics where she was a Clinical Program Director overseeing the clinical development, strategy and conduct of trials evaluating plasma-derived proteins in orphan and rare disorders. She has over 15 years of experience in oversight and management of Phase 1 through 4 clinical trials conducted in many regions of the world. She has been involved with filing of pre-IND, IND and NDA submissions. Dr. Jain received her Ph.D. from the School of Medicine, Department of Biochemistry, East Carolina University and her M.S. from University of Connecticut from the Department of Molecular Biology.