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Enrollment begins for phase 2a trial of hepatic encephalopathy therapy

Mallinckrodt announced the first patient has been enrolled in a phase 2a trial comparing MNK-6106, an L-ornithine phenylacetate, with Xifaxan for the treatment of liver cirrhosis and hepatic encephalopathy, according to a press release.

“Enrollment of the first patient in this clinical trial of investigational drug MNK-6106 marks another important milestone in the compound’s development program,” Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt, said. “The evaluation of the oral formulation will allow us to gain insights into the potential utility of this compound to manage patients whose acute episode of [hepatic encephalopathy] has resolved, and who may require longer-term treatment to reduce the likelihood of future episodes and potential complications.”

The phase 2a trial will comprise approximately 48 patients with cirrhosis, two or more documented episodes of hepatic encephalopathy within the previous 12 months, and hyperammonemia at the time of screening. Investigators will randomly assign patients to receive MNK-6106 at one of three doses or Xifaxan (rifaximin, Salix Pharmaceuticals).

Mallinckrodt expects study completion by the first quarter of 2020. Additionally, the company expects to begin recruiting for a phase 3 clinical trial of MNK-6105, another L-ornithine phenylacetate, in patients hospitalized for acute hepatic encephalopathy.

Reference: www.mallinckrodt.com