View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
June 4, 2017

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

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU