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Ocera launches trial of ornithine phenylacetate for patients with cirrhosis
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Ocera Therapeutics Inc. announced a phase 1 clinical trial of oral ornithine phenylacetate in patients with cirrhosis. The drug — which also comes in IV form — is believed to be the only ammonia scavenger in clinical development for treatment and prevention of hepatic encephalopathy.
“Based on the favorable results from last year’s proof-of-principle study in healthy volunteers, we are keen to assess our oral drug candidate for the first time in patients with cirrhosis, the intended population for the drug’s chronic use,” Stan Bukofzer, MD, chief medical officer at Ocera, said in a press release. “In healthy volunteers, oral [ornithine phenylacetate (OCR-002, Ocera)] demonstrated significant bioavailability, as measured by the mean plasma concentration of the drug’s active ingredient phenylacetic acid (PAA) and exhibited substantial concentrations of plasma and urinary phenylacetylglutamine (PAGN), the end product by which PAA clears the neurotoxin ammonia.”
The phase 1 trial is a two-part, open-label crossover study intended to comprehend pharmacokinetics, plasma and urinary PAGN formation, and the absolute bioavailability of oral immediate-release doses of OCR-002 in 12 patients with varying degrees of cirrhosis, according to Bukofzer. In the first part, researchers will administer a single dose to patients with various degrees of stomach fullness with either Child-Pugh A or C that reflects the severity of the patient’s liver disease. In the second part, researchers will assess the effects of a multi-dose solid form regimen and resultant steady-state pharmacokinetics.
If results — due by the end of June 2017 — are satisfactory, a phase 2 development program for oral OCR-002 will begin.
Trials of IV OCR-002 — a potential treatment for hospitalized patients with acute hepatic encephalopathy — are also in progress.
“We believe we are closer to realizing our vision of providing continuity of care to [hepatic encephalopathy] patients,” Bukofzer said in the release.
Disclosure: Bukofzer is employed by Ocera.