Breakthrough therapy to treat NASH initiates pivotal Phase 3 clinical trial

Today, Inventiva announced that it has initiated a phase 3 clinical trial called NATiV3 to evaluate the efficacy and safety of its lead drug candidate, lanifibranor, in the treatment of non-alcoholic steatohepatitis (NASH)

NASH is a progressive liver disease caused by excessive accumulation of fat in the liver.

Lanifibranor is an oral small-molecule pan-PPAR agonist, which produces a balanced activation of PPARα and PPARδ, and can partially activate PPARγ, inducing anti-fibrosis, anti-inflammatory responses, and beneficial vascular and metabolic changes in the body

▲Lanifibranor's mechanism of action targets a variety of key features of NASH (picture source: Inventiva official website)

In the completed phase 2b clinical trial, lanifibranor reached the primary endpoint

The first part of this randomized, double-blind, placebo-controlled phase 3 clinical trial is expected to enroll approximately 900 biopsy-confirmed non-cirrhotic NASH patients with liver fibrosis levels of F2/F3

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Reference materials:

[1] Inventiva announces the initiation of its pivotal Phase III clinical trial evaluating lanifibranor in NASH.