Inventiva stock climbs 25% on delayed data from phase 2 liver disease trial

Inventiva finally has data from a midphase clinical trial of lanifibranor in patients with Type 2 diabetes and nonalcoholic fatty liver disease (NAFLD). Almost four years behind schedule, the investigator-initiated study has linked the candidate to reductions in liver fat—and triggered a 25% jump in the biotech’s share price.

The study compared lanifibranor, a pan-PPAR agonist, to placebo in 38 patients. After 24 weeks of daily treatment, the investigators saw a 44% reduction in intrahepatic triglycerides, a measure of liver fat, in the lanifibranor cohort, compared to a 12% decline in the placebo group. The difference was big enough for the study to hit its primary endpoint. 

Inventiva highlighted success against a range of other endpoints while also noting that the study needed to impute some missing data. The readout sent shares in the French biotech up 25% in early trading in Paris, where its stock price rose to 4.24 euros ($4.56) in the hours after the market opened. 

While investors welcomed the news, delays to the trial have dulled its impact. The study was originally designed to enroll 74 patients and have its primary completion late in 2019. If the investigators had stuck to the original timeline, they may have presented data before Inventiva released phase 2b data from its own study.

The Inventiva study targeted nonalcoholic steatohepatitis (NASH), rather than the milder NAFLD treated in the investigator-initiated trial, and only 42% of the participants had Type 2 diabetes. But the size of the study, which enrolled 247 patients, and use of endpoints that matter most to regulators make it the clearest guide to date for the prospects of lanifibranor.

Inventiva moved lanifibranor into a phase 3 NASH clinical trial in 2021 but is still two years away from reporting top-line data. The next milestone (PDF) is the release of results from a phase 2 study that is testing lanifibranor in combination with the SGLT2 inhibitor empagliflozin, sold by Boehringer Ingelheim and Eli Lilly as Jardiance, in patients with NASH and Type 2 diabetes. The data are due later this year.

Money is a concern. Inventiva ended (PDF) March with 56.3 million euros ($60.8 million) in cash and equivalents and forecast the sum, plus other deposits, would keep it going into the fourth quarter. The biotech could access 25 million euros ($27 million) under a loan agreement if it meets the conditions.