Hepion Pharmaceuticals’ Phase 2 Clinical Trial Meets Primary and Secondary Endpoints

Hepion Pharmaceuticals (Nasdaq: HEPA) has announced positive topline results from its recently completed Phase 2 ALTITUDE-NASH clinical trial.

The company is focused on AI-assisted therapeutic drug development for the treatment of non-alcoholic steatohepatitis (NASH), fibrotic diseases, hepatocellular carcinoma, and other chronic diseases.

Highlights

The company’s ALTITUDE-NASH study met its primary endpoint by demonstrating improved physiologic liver function and was well tolerated after four months of treatment in subjects with stage 3 or greater fibrosis.

All additional secondary endpoints were met, including reductions in liver injury biomarkers, and multiple fibrosis-associated biomarkers.

67 of 70 subjects enrolled in the study completed all study procedures including 120 days of oral dosing of rencofilstat with a 14-day routine safety follow up period.

Hepion is now recruiting for its Phase 2b ASCEND-NASH biopsy trial.

About Hepion Pharmaceuticals

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 observable differences 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.