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New kid on the block in race for NASH drug

  • French biopharma Inventiva (OTCPK:IVEVF) has emerged as a new player in the pursuit of a treatment for nonalcoholic steatohepatitis (NASH).
  • Today, it announced positive results from a Phase 2 clinical trial, NATIVE, evaluating lanifibranor in adult NASH patients with liver steatosis and moderate-to-severe necroinflammation without cirrhosis.
  • The trial met the primary endpoint in the intent-to-treat population (1200 mg/day), demonstrating a statistically significant proportion of patients experiencing a decrease of at least two points in SAF (combines hepatocellular inflammation and ballooning) activity score at week 24 with no worsening of fibrosis. Specifically, 49% of treated participants achieved the endpoint, compared to 27% in the placebo arm.
  • Key secondary endpoints were also met.
  • The company says lanifibranor, a pan-PPAR (peroxisome proliferator-activated receptors) agonist, is the first drug candidate to show statistically significant results on the two FDA and EMA primary efficacy endpoints relevant to potential accelerated approval during Phase 3 development.
  • The company's current cash runway extends into Q3 2021, but the company is "open to all options" related to raising additional capital.
  • Next up are meetings with regulators before advancing into late-stage studies.
  • PPARs have stuck out so far in treating NASH. Genfit's (NASDAQ:GNFT) elafibranor flopped in a Phase 3 study while CymaBay Therapeutics (NASDAQ:CBAY) terminated a Phase 2b trial of seladelpar on a potential safety signal, although shares rallied a month ago after the company announced that further analyses support a restart.
  • Inventiva says lanifibranor is different, since it targets all three types of PPAR instead of just one.
  • NASH-related tickers: MDGL, VKTX, ICPT, ABBV

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