Inventiva fell sharply on the stock market on Friday morning, following the announcement of the suspension of recruitment for its Phase III clinical trial in NASH due to a potential serious adverse event.

The French biopharmaceutical company's share price fell by almost 17% at around 10.45 a.m., marking the biggest drop on the Paris market.

In a press release published after the close of trading on Thursday, Inventiva explained that it had decided to voluntarily and temporarily suspend the screening and randomization of new patients in order to implement new eligibility criteria.

The company justified its decision by the appearance of an adverse event characterized by an elevation of liver tests in a patient randomized in the study.

It points out that this is the first serious incident reported in all clinical trials involving lanifibranor, its most advanced drug candidate.

Patients already randomized in the study continue to receive treatment according to a new liver monitoring schedule, but the need to make changes to the study protocol means that screening and randomization will not be able to restart for another four to six weeks.

This pause is expected to push back the first visit of the last patient to the first half of 2024.

The 'NATiV3' study is investigating lanifibranor in the treatment of adult patients with NASH, a common and progressive chronic liver disease for which there is currently no treatment.

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