Innovative drugs for treating NASH reach all primary endpoints of Phase 2a trial

On July 13, 2021, Hepion Pharmaceuticals announced that in patients with non-alcoholic steatohepatitis (NASH), its phase 2a AMBITION clinical trial of the novel cyclophilins inhibitor CRV431 has achieved positive top-line results , To reach all the main endpoints of the trial

This randomized single-blind, multi-center, placebo-controlled Phase 2a clinical trial aims to study the safety, tolerability and drug resistance of CRV431 in NASH patients with moderate (F2) or advanced (F3) liver fibrosis.

Previous studies have shown that the reduction of alanine aminotransferase (ALT) in patients' serum may be a surrogate indicator for histological improvement of NASH

▲Compared with the placebo group in the trial, the CRV431 cohort of different doses showed a statistically significant decrease in ALT (picture source: reference [1])

The test results also showed that CRV431 at the two study doses was well tolerated, no serious adverse events (SAE) occurred, and the few observed adverse events (AE) were mostly mild and not related to the study drug

The trial successfully determined the drug dosage range for the upcoming Phase 2b trial

CRV431 is an innovative oral drug candidate targeting NASH and viral hepatitis to induce liver disease.

▲The mechanism of CRV431 (picture source: Hepion official website)

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Reference materials:

[1] Hepion Pharmaceuticals Announces Positive Topline Data from Phase 2a'AMBITION' NASH Trial; All Primary Endpoints Achieved.