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Inventiva Revises Phase III NASH Plans For Broader Indication

 
• By Joseph Haas

While plans to obtain accelerated approval of lanifibranor remain unchanged, Inventiva now plans to conduct the confirmatory Phase III in cirrhotic patients, meaning a shorter trial duration and possibly broader label.

Change of plans
Inventiva's revised Phase III NASH plans involve testing drug in cirrhotic patients • Source: Shutterstock

Inventiva S.A. has restructured its pivotal Phase III program for lanifibranor in non-alcoholic steatohepatitis (NASH) so that a planned confirmatory study to support full approval will be shorter in duration and require only two liver biopsies for patients, rather than the previously planned three.

Lanifibranor is a pan-PPAR agonist that demonstrated the ability in a Phase IIb study to reduce fibrosis, resolve NASH and improve hepatocellular inflammation and ballooning in June of 2020. (Also see "Inventiva Moves Up In NASH, Hitting Multiple Phase IIb Endpoints" - Scrip, 17 June, 2020

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