FDA grants orphan drug designation to rencofilstat for hepatocellular carcinoma

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The FDA granted orphan drug designation to rencofilstat for treatment of hepatocellular carcinoma, according to the agent’s manufacturer.

Rencofilstat (Hepion Pharmaceuticals), a novel, potent cyclophilin inhibitor, is in clinical-phase development for treatment of nonalcoholic steatohepatitis (NASH), a major cause of HCC.

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The agent has been shown in experimental NASH models to lower liver fibrosis and HCC tumor burden, according to a Hepion Pharmaceuticals press release. It received FDA fast track designation last year for treatment of NASH.

“Orphan drug designation for rencofilstat in HCC represents a significant milestone for Hepion and its recognition by the FDA of the potential for rencofilstat to address a significant unmet medical need for patients suffering from this aggressive cancer,” Robert Foster, PharmD, PhD, CEO of Hepion, said in the release. “In addition to two phase 2 studies in patients with NASH, we remain on track to initiate patient enrollment in a phase 2a study of rencofilstat in HCC in the third quarter of 2022.”

Hepion plans to use its proprietary artificial intelligence platform, AI-POWR, to help identify patients with NASH who will best respond to rencofilstat, as well as other possible indications for the treatment.

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