Efficacy, safety of oral Mogrovir, ribavirin confirmed for HCV

Oral-dosing mogroside IV, combined with ribavirin, appeared to be safe and effective in treatment-naive patients with genotype 1 hepatitis C virus, according to a press release.

Twenty-eight patients who received the toll-like receptor agonist mogroside IV (Mogrovir, Canopus BioPharma) and ribavirin twice daily showed significantly improved liver function in a 3-month compassionate clinical trial in China, the drugmaker said. Blood platelet counts, malaise, anorexia, food intake, abdominal distension and sleep also improved.

After another 90 days of follow-up, hepatitis C (HCV) viral load neared zero in a segment of participants, confirming Mogrovir’s immune activation effects, the release said. There were no reports of toxicity or negative side effects, according to Canopus BioPharma.

Canopus BioPharma currently is coordinating with US and European study centers to duplicate the results observed in this trial and is raising funds to conduct additional studies and gain marketing approvals from the FDA and European and Australian regulators.

"As a result of the compassionate trial in China our company and its investors have great confidence in initiating two further patient studies," Patrick T. Prendergast, chairman and CEO of Canopus BioPharma, told Healio.com/Gastroenterology. "These studies will be designed to demonstrate efficacy as an immune stimulatory therapy to clear dengue and HCV."

Genotype 1 HCV, the most-resistant strain to standard antiviral therapies, accounts for an estimated 34% to 38% of the 36 million people in China with HCV, according to the release.