Inventiva receives FDA Breakthrough Therapy designation for lead drug candidate lanifibranor in NASH
- Designation based on positive topline results from NATIVE Phase IIb clinical trial evaluating lanifibranor in non-alcoholic steatohepatitis (NASH)
- Lanifibranor believed to be the first drug candidate to receive Breakthrough Therapy designation in NASH since 2015
- There are currently no FDA-approved treatments for this common and progressive chronic liver disease
- This designation further supports the decision to initiate a Phase III pivotal clinical trial with lanifibranor in H1 2021
Daix (France), October 12, 2020 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to lanifibranor, the Company’s lead drug candidate, for the treatment of NASH. Lanifibranor is believed to be the first drug candidate to be granted this status for the treatment of NASH since January 2015.
The Breakthrough Therapy designation by the FDA is intended to expedite the development and review of drug candidates for serious or life-threatening conditions. To qualify for this designation, drug candidates must show preliminary clinical evidence that they may demonstrate a substantial improvement on at least one clinically significant endpoint over available therapies or over placebo if there are no approved therapies.
The designation of lanifibranor as a Breakthrough Therapy for the treatment of NASH follows the publication in June 2020 of positive topline results from Inventiva’s NATIVE Phase IIb clinical trial with lanifibranor in NASH patients. In this 24-week clinical trial, lanifibranor met the primary endpoint with a statistically significant reduction of the Steatosis Activity Fibrosis score (SAF), which combines assessments of hepatocellular inflammation and ballooning with no worsening of fibrosis in the Intention To Treat (ITT1) and Per Protocol populations (PP2). In addition, lanifibranor met key secondary endpoints, including NASH resolution with no worsening of fibrosis3 and improvement of liver fibrosis with no worsening of NASH4 in both ITT and PP populations. With regards to the secondary endpoints, lanifibranor is the first drug candidate to achieve statistically significant results on the FDA and European Medicine Agency (EMA) primary endpoints which are relevant for seeking accelerated approval during Phase III clinical development.
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