Ocera doses first patient in Phase IIa trial of OCR-002 to treat cirrhosis

4th June 2017 (Last Updated June 4th, 2017 18:30)

Ocera Therapeutics has started dosing patients in the Phase IIa part of its Phase I/IIa clinical trial of oral OCR-002 (ornithine phenylacetate) for the treatment of cirrhosis.

Ocera Therapeutics has started dosing patients in the Phase IIa part of its Phase I/IIa clinical trial of oral OCR-002 (ornithine phenylacetate) for the treatment of cirrhosis.

OCR-002 is a validated ammonia scavenger currently being developed as a step-down therapy to retain remission of a neurocognitive disorder called hepatic encephalopathy (HE), which is caused due to serious liver disease.

The open-label, multiple-dose, randomised, three-period crossover Phase IIa part of the trial will assess the steady-state pharmacokinetics and pharmacodynamics of three times daily 6g, 12g and 21g of oral OCR-002 in 18 patients with Child-Pugh B cirrhosis.

The top-line results from this part of the trial are expected to be reported by the end of this year.

Ocera Therapeutics CEO Linda Grais said: "Patients with cirrhosis continue to have significant breakthrough episodes of HE, even with the 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 hospitalisation for an acute episode of overt HE, in order to prevent re-hospitalisation and relapse of HE."

“Our initial focus will be as a step-down therapy for patients following hospitalisation for an acute episode of overt HE, in order to prevent re-hospitalisation and relapse of HE."

The firm previously reported positive findings from the open-label, cross-over Phase I part of the trial.

The Phase I part was designed to determine the pharmacokinetics and the absolute oral bioavailability of single 5g doses of IV OCR-002 and single 5g doses of a liquid oral solution of OCR-002 in patients with Child-Pugh A and C cirrhosis.

The results showed that OCR-002 was safe and well-tolerated, with an absolute oral bioavailability of more than 95%.


Image: Illustration comparing a normal liver with a liver affected by cirrhosis. Photo: courtesy of BruceBlaus.