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

 Last Update: 2021-09-19
 Source: Internet
 Author: User

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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.

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