French biopharmaceutical company, Inventiva has paused recruitment for its pivotal Phase III trial for lanifibranor after a trial participant reported a possible treatment-related serious adverse event.

Inventiva’s CEO Frédéric Cren was quick to add that this was the first treatment-related serious adverse event for lanifibranor across all trials and the “patient has been asymptomatic and blood tests are improving”. According to the company, the study is expected to resume in four to six weeks, with the patient enrolment and randomisation due to completed in H1 2024.

Following the news, Inventiva’s stock was down by over 16% in pre-market trading today. The company’s market cap stands at $208.49m.

The Phase III NATiV3 trial is evaluating lanifibrator in adult patients with non-alcoholic steatohepatitis (NASH). The study has enrolled and randomised 913 patients to date. The adverse event experienced by the patient was an elevated aminotransferases, indicating liver damage. The company noted that the patient likely had autoimmune hepatitis based on the lab results and a liver biopsy conducted by the company following trial discontinuation. The patient had a baseline histological diagnosis of NASH with stage 2 fibrosis.

The modifications recommended by the Data Monitoring Committee for the trial going forward include liver monitoring every six weeks for each patient, and an amendment to the protocol to exclude newly screened patients diagnosed or with a predisposition to autoimmune liver or thyroid disease. The patients currently enrolled will receive treatment under the new monitoring schedule.

The NATiV3 trial was designed to inform the regulatory approval of lanifibranor. The company modified the clinical development plan of lanifibranor for the treatment of NASH and changed the NATiV3 trial design in January 2023. Some of the implemented changes include a reduction in the number of patient biopsies, a reduction in trial duration from seven years to 72 weeks, and potentially expanding the addressable patient population to include patients with NASH and compensated cirrhosis.

Lanifibrator is a peroxisome proliferator active receptor alpha (PPARα) agonist. In October 2023, Inventiva licensed the therapy’s development and commercialisation rights in Japan and South Korea to Hepalys Pharma. The French company received $10m in upfront payment, owns a 30% stake in Hepalys, and could receive up to $231m in milestone-based payments.

In September 2022, the company also licenced the therapy’s development and commercialisation rights in mainland China, Hong Kong, Macau and Taiwan to Sino Biopharm’s subsidiary, Chia Tia Tianquing Pharmaceutical (CTTQ).

Inventiva received $5m in milestone payments from CTTQ after investigational new drug (IND) approval from the Chinese National Medical Products Administration (NMPA) to initiate the clinical development in mainland China of lanifibranor in NASH, and the randomisation of the first patient.