(Boursier.com) — Inventive drop of 16% this Friday to 3 euros, after having reviewed its accounts and its NATiV3 clinical study. As of December 31, 2023, Inventiva recorded 26.9 million euros of cash and cash equivalents and 0.01 million euros of short-term deposits, and a long-term deposit of 9 million euros, compared to 86,000,000 euros. 7 million euros, 1 million euros and 0.7 million euros respectively as of December 31, 2022.
Update on the Phase III NATiV3 clinical study with lanifibranor
Following a scheduled visit in the NATiV3 study, an adverse event characterized by elevated liver tests was reported in a patient randomized to the study and evaluated as a suspected unexpected serious adverse reaction ( SUSAR) related to the treatment… The 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 period of observation. Additional medical tests and a liver biopsy performed after discontinuation of study treatment revealed findings consistent with autoimmune hepatitis. This patient initially presented, in September 2022, with a histological diagnosis of NASH with stage 2 fibrosis. A previous diagnostic analysis had raised a suspicion of autoimmune hepatitis dating back to June 2022.
SUSAR was duly reported to all regulatory authorities and reviewed by the DMC in conjunction with other more benign cases of aminotransferase elevations among study participants. The DMC subsequently recommended that the NATiV3 study continue with the following modifications:
-Hepatic monitoring every 6 weeks for each patient and;
-Modification of the protocol in order to exclude newly screened patients who are diagnosed or who present a predisposition to autoimmune hepatic or thyroid diseases.
Quoting…
Work in progress
Following the DMC’s review of the data, Inventiva made the decision to voluntarily and temporarily suspend screening and randomization for the clinical study in order to implement the DMC’s recommendations. Patients already randomized into the study continue to receive treatment according to the new liver monitoring schedule recommended by the DMC.
Inventiva is actively working to make necessary changes to the study protocol and Consent Form in accordance with DMC recommendations and plans to restart screening and randomization in four to six weeks, once operational implementation is complete. The company anticipates that the screening pause could push the first visit of the last patient for NATiV3 to the first half of 2024.
This SUSAR is the first reported in all clinical studies with lanifibranor. Prior to this voluntary suspension, Inventiva was on track to complete screening by the end of the first quarter of 2024 with more than 550 patients currently being screened and 913 randomized to NATiV3, including 731 in the main cohort.
The pause in screening and randomization in the NATiV3 study does not affect the publication of the main results of Phase IIa, LEGEND, evaluating lanifibranor in combination with empagliflozin, scheduled for the first quarter of 2024.
News deemed “not encouraging” by Portzamparc, but which should nevertheless be well managed by the company, first announcement of its kind concerning lanifibranor, which explains why the analyst does not change his opinion on the purchase, nor its price target of 14.60 euros.