The latest phase 2 results of NASH's innovative therapies are announced, significantly reducing the level of fibrosis biomarkers

On September 13, 2021, Hepion Pharmaceuticals announced the additional efficacy data of the phase 2a clinical trial AMBITION of the new cyclophilins inhibitor CRV431 under investigation

A total of 43 NASH patients were enrolled in the multicenter, randomized single-blind, placebo-controlled AMBITION

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

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

This additional data shows:

In subjects with baseline Pro-C3 levels> 17.

Pro-C3 levels> 15-20 ng/mL are generally considered to represent the main patient population for active NASH disease and many NASH drug candidates

Pharmacokinetic-pharmacodynamics (PK-PD) and transcriptomics analysis found that CRV431 treatment produced gene expression changes consistent with anti-fibrosis effects

The PK-PD model successfully predicted the reduction of Pro-C3 and ALT.

Reference materials:

[1] 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.

[2] PRO-C3 as a NASH Biomarker.