Hepion Pharmaceuticals Highlights Upcoming Phase 2 Clinical Trials of Recofilstat at 5th Global NASH Congress
Hepion Pharmaceuticals, Inc. recently announced that its Chief Medical Officer, Todd Hobbs, MD, gave a clinical presentation titled Recofilstat (CRV431): A liver-targeting drug candidate for NASH and HCC at the 5th Global NASH Congress.
During the presentation, Dr. Hobbs reviewed additional data from the positive Phase 2a AMBITION NASH clinical trial, and provided further details on three upcoming clinical studies of its lead drug candidate, rencofilstat:
- ASCEND-NASH: a 12-month Phase 2b clinical trial clinical trial in biopsy-proven F2/F3 NASH subjects
- ALTITUDE-NASH: a 4-month Phase 2 liver function trial in NASH F3 subjects
- HEPA-CRV431-209: a 4-month Simon Two-Stage Phase 2a study in HCC
The initiation of screening and enrollment in all three studies is currently expected to begin in the third quarter of 2022.
“We are very pleased to have been selected to share both the positive AMBITION study data and our upcoming clinical trial plans for rencofilstat in NASH and HCC with clinicians, researchers, and regulators at this prestigious and clinically focused NASH congress,” said Dr. Hobbs. “The Hepion team has been hard at work over this past year preparing the clinical plans for these upcoming trials, and it is exciting to share details of these trials and look forward to when we soon begin to enroll subjects for all three.”
A copy of Dr. Hobbs’ presentation is accessible on the Company’s website at www.hepionpharma.com under “Publications” in the Pipeline section.
The company’s lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease – from triggering events through to end-stage disease. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH, and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies. In November 2021, the US FDA granted Fast Track designation for rencofilstat for the treatment of NASH. That was soon followed in December 2021 by the FDA’s acceptance of Hepion’s investigational new drug (IND) application for rencofilstat for the treatment of hepatocellular carcinoma (HCC).
Hepion has created a proprietary AI platform, called AI-POWR, which stands for Artificial Intelligence – Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR to help identify which NASH patients will best respond to rencofilstat, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for rencofilstat to expand the company’s footprint in the cyclophilin inhibition therapeutic space.
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