Ocera Initiates Phase 2a Study with Oral OCR-002 in Patients with Cirrhosis
Results Expected by Year-End 2017
REDWOOD CITY, Calif. and RESEARCH TRIANGLE PARK, N.C., June 01, 2017 (GLOBE NEWSWIRE) -- Ocera Therapeutics, Inc. (NASDAQ:OCRX), today announced the dosing of the first patients in Part Two of a Phase1/Phase 2a clinical trial of oral OCR-002 (ornithine phenylacetate). Oral OCR-002 is a validated ammonia scavenger in development for use as a step-down therapy and for chronic use to maintain remission of hepatic encephalopathy (HE), a neurocognitive disorder associated with serious liver disease.
The Phase 2a portion of the trial is an open-label, multiple-dose, randomized, 3-period crossover study. It is designed to evaluate the steady-state pharmacokinetics and pharmacodynamics of three times daily administration of three daily dose regimens, 6, 12 and 21 grams, of OCR-002 tablets in 18 patients with Child-Pugh1 B cirrhosis. We expect to complete the trial and report top-line results by the end of 2017.
"Advancing oral OCR-002 into Phase 2a marks another significant milestone in the progression of our pipeline and programs for orphan and other serious liver diseases," said Linda Grais, Chief Executive Officer of Ocera.
"Patients with cirrhosis continue to have significant breakthrough episodes of HE, even with current standard of care for HE prevention. We are developing an oral formulation to address this need. Our initial focus will be as a step-down therapy for patients following hospitalization for an acute episode of overt HE, in order to prevent re-hospitalization and relapse of HE."
About the Part1/Phase 1 Orally-Available OCR-002 Study
The Phase 1 trial was an open-label, crossover study to determine the pharmacokinetics and the absolute oral bioavailability of OCR-002 in patients with Child-Pugh1 A and C cirrhosis. The study evaluated a single 5g dose of IV OCR-002, and single 5g doses of a liquid oral solution of OCR-002 administered under various fasted and fed conditions.
Summary of Key Findings:
OCR-002 was observed to be safe and well-tolerated across all treatment arms in the study.
OCR-002 demonstrated absolute oral bioavailability of greater than 95% in the fasted state.
Dosing under fed conditions showed a beneficial food effect.
A well-characterized pharmacokinetic profile was established.
http://ir.ocerainc.com/releasedetail.cfm?ReleaseID=1028644
Results Expected by Year-End 2017
REDWOOD CITY, Calif. and RESEARCH TRIANGLE PARK, N.C., June 01, 2017 (GLOBE NEWSWIRE) -- Ocera Therapeutics, Inc. (NASDAQ:OCRX), today announced the dosing of the first patients in Part Two of a Phase1/Phase 2a clinical trial of oral OCR-002 (ornithine phenylacetate). Oral OCR-002 is a validated ammonia scavenger in development for use as a step-down therapy and for chronic use to maintain remission of hepatic encephalopathy (HE), a neurocognitive disorder associated with serious liver disease.
The Phase 2a portion of the trial is an open-label, multiple-dose, randomized, 3-period crossover study. It is designed to evaluate the steady-state pharmacokinetics and pharmacodynamics of three times daily administration of three daily dose regimens, 6, 12 and 21 grams, of OCR-002 tablets in 18 patients with Child-Pugh1 B cirrhosis. We expect to complete the trial and report top-line results by the end of 2017.
"Advancing oral OCR-002 into Phase 2a marks another significant milestone in the progression of our pipeline and programs for orphan and other serious liver diseases," said Linda Grais, Chief Executive Officer of Ocera.
"Patients with cirrhosis continue to have significant breakthrough episodes of HE, even with current standard of care for HE prevention. We are developing an oral formulation to address this need. Our initial focus will be as a step-down therapy for patients following hospitalization for an acute episode of overt HE, in order to prevent re-hospitalization and relapse of HE."
About the Part1/Phase 1 Orally-Available OCR-002 Study
The Phase 1 trial was an open-label, crossover study to determine the pharmacokinetics and the absolute oral bioavailability of OCR-002 in patients with Child-Pugh1 A and C cirrhosis. The study evaluated a single 5g dose of IV OCR-002, and single 5g doses of a liquid oral solution of OCR-002 administered under various fasted and fed conditions.
Summary of Key Findings:
OCR-002 was observed to be safe and well-tolerated across all treatment arms in the study.
OCR-002 demonstrated absolute oral bioavailability of greater than 95% in the fasted state.
Dosing under fed conditions showed a beneficial food effect.
A well-characterized pharmacokinetic profile was established.
http://ir.ocerainc.com/releasedetail.cfm?ReleaseID=1028644
