Investors in Inventiva (NASDAQ:IVA) received sobering news as shares plummeted in Paris following the biotech company’s revelation of a delay in its Phase 3 trial for lanifibranor, a candidate drug for treating NASH (nonalcoholic steatohepatitis). The adverse event tied to the study drug triggered the slump.

NASH stands for nonalcoholic steatohepatitis—precisely, the hefty accumulation of liver fat. An advanced form of nonalcoholic fatty liver disease, NASH presents a substantial unmet medical need, as there are currently no FDA-approved therapies.

In addition to this development, the company unveiled its preliminary financials for 2023. Lanifibranor hails from the family of peroxisome-activated receptor (PPAR) agonists, a drug class that is making waves in the field.

Joining the liver-targeting PPAR agonists fray are heavyweights such as Gilead’s (GILD) new acquisition target, CymaBay Therapeutics (CBAY), and Inventiva’s (IVA) French counterpart, Genfit (GNFT) (OTCPK:GNFTF).

Revealing that the adverse event was treatment-related, Inventiva (IVA) has taken the difficult decision to discontinue lanifibranor therapy in the affected patient. Subsequent findings indicated results consistent with autoimmune hepatitis, intensifying the setback.

Following a thorough review of the data, the trial’s data monitoring committee recommended changes to the trial design. Consequently, Inventiva (IVA) opted to halt the screening and randomization of new patients to incorporate the committee’s recommendations, leading to a delay.

The company anticipates a resumption of screening and randomization in approximately 4–6 weeks. However, due to this snag, its plans for the last patient’s first visit face a postponement to the second half of 2024 from the previous target of the first quarter of 2024.