The Food and Drug Administration (FDA) has granted Fast Track designation to CRV431 for the treatment of nonalcoholic steatohepatitis (NASH).

CRV431 works by specifically binding to cyclophilin isomerase enzymes and inhibiting cyclophilin function with high potency. In preclinical studies, CRV431 was found to reduce liver fibrosis and hepatocellular carcinoma tumor burden. In in vitro studies, it has demonstrated antiviral activities toward hepatitis B, C, and D viruses.

The Company is currently investigating CRV431 in adults with presumed F2 and F3 NASH in the ongoing multicenter, randomized, placebo-controlled AMBITION trial (ClinicalTrials.gov Identifier: NCT04480710). Findings from the phase 2a portion of the trial showed that CRV431 demonstrated anti-inflammatory and antifibrotic effects with reductions in N-terminal type III collagen pro-peptide (Pro-C3) and alanine aminotransferase (ALT).

“This Fast Track designation provides for early and frequent communication with the FDA that will continue throughout the drug development and review process, which may lead to a more expedited drug approval and patient access to CRV431,” said Robert Foster, PharmD, PhD, Hepion’s CEO. “Additionally, as part of the FDA Fast Track designation for CRV431 in NASH, Hepion will make its expanded access policy publicly available in the coming weeks.”

References

  1. Hepion Pharmaceuticals receives FDA Fast Track designation for CRV431 for the treatment of NASH. News release. Hepion Pharmaceuticals, Inc. Accessed November 30, 2021. https://www.globenewswire.com/news-release/2021/11/30/2343013/0/en/Hepion-Pharmaceuticals-Receives-FDA-Fast-Track-Designation-for-CRV431-for-the-Treatment-of-NASH.html
  2. Additional data from Hepion Pharmaceuticals’ phase 2a ‘AMBITION’ trial further strengthens CRV431 clinical profile and paves way for initiation of phase 2b ‘ASCEND-NASH’ clinical program. News release. Hepion Pharmaceuticals, Inc. September 13, 2021. Accessed November 30, 2021. https://hepionpharma.com/news/additional-data-from-hepion-pharmaceuticals-phase-2a-ambition-trial-further-strengthens-crv431-clinical-profile-and-paves-way-for-initiation-of-phase-2b-ascend-nash-clinical-program/.