FDA Gives Green Signal To Inventiva's Mid-Stage Lanifibranor Study In NASH Patients

The FDA has completed a safety review of Inventiva SA's IVA IND application and signed off Phase 2 combination trial with its lead drug candidate, lanifibranor.

• The planned Phase 2 trial, LEGEND3, has been designed as a proof-of-concept trial to assess the safety and efficacy of lanifibranor combined with empagliflozin for non-cirrhotic NASH and Type 2 Diabetes (T2D). 
• LEGEND is expected to recruit a total of 63 non-cirrhotic non-alcoholic steatohepatitis (NASH) patients with T2D.
• Related: Inventiva Posts Results of Clinical Thorough QT Study Of Lanifibranor.
• The trial's primary efficacy endpoint is a change in Hemoglobin A1c (HbA1c) at the end of the 24-week treatment compared to baseline. Secondary endpoints include changes in liver enzymes, glycaemic and lipids parameters, inflammatory markers, and body fat composition. 
• The trial will be initiated in 1H of 2022, and top line results are expected for 2H of 2023.
• Price Action: IVA shares closed 3.53% lower at $10.94 on Monday.