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

https://seekingalpha.com/news/3583247-new-kid-on-block-in-race-for-nash-drug