Inventiva: After a potential serious effect on a patient, Inventiva must pause its clinical trials

(BFM Bourse) – The stock price of the Burgundy biotechnology firm falls after bad news in the context of a clinical study concerning lanifibranor, its most advanced drug candidate against soda sickness.

While the Paris Stock Exchange keeps setting records, certain stocks are not participating in the party. Including Inventiva which fell by 17%, showing the biggest drop in the Parisian market, after announcing bad news in its clinical trials concerning lanifibranor, its most advanced drug candidate against soda sickness.

This potential treatment against this disease is currently being evaluated as part of the pivotal Phase III clinical study (last stage of clinical trials before possible marketing) NATiV3 for the treatment of adult patients suffering from non-alcoholic steatohepatitis (Nash).

This pathology is also known as “soda disease”, a pathology characterized by an influx of fat towards the liver which can cause damage up to cirrhosis and cancer. To date, there is no approved treatment for this disease.

First reported incident

And Thursday evening after the close of the markets, the company based in Daix indicated that it had “voluntarily and temporarily” suspended the screening – that is to say the selection – and the randomization – or random distribution – of new patients as part of the NATiV3 study. The aim is to rectify the situation by implementing new eligibility criteria in accordance with the recommendations of the Data Monitoring Committee (a surveillance and monitoring committee responsible for monitoring clinical trial data).

This decision follows a potential unexpected serious adverse effect related to the treatment, which was characterized by an elevation in liver tests in a patient randomized to the study.

“Treatment was suspended for the patient and his liver tests which are closely monitored by the clinical site are improving, and the patient did not present any clinical symptoms during the entire observation period,” specifies Inventiva. The Burgundian firm claims that this is the first incident reported in all clinical studies with lanifibranor.

Before this voluntary suspension, Inventiva said it was on track to complete the selection of patients by the end of the first quarter of 2024. However, the company must make necessary modifications to the study protocol in order to restart screening and randomization within “four to six weeks”, according to the indicative timetable provided by the company. This pause should therefore postpone the first visit of the last patient for NATiV3 to the first half of 2024.

This pause in the NATiV3 study does not affect the publication of the main results of Phase IIa of its LEGEND study scheduled for the first quarter of 2024. It evaluates lanifibranor in combination with empagliflozin, in type 2 diabetic patients.

Sabrina Sadgui – ©2024 BFM Bourse