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.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
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.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“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.
