Inventiva Resumes NATiV3 Phase III NASH Clinical Trial Screening

Inventiva, a biopharmaceutical firm dedicated to developing oral small molecule therapies for conditions like non-alcoholic steatohepatitis (NASH), has resumed patient screening and randomization in its NATiV3 clinical trial. This follows the US central Institutional Review Board's (IRB) endorsement of protocol and Informed Consent Form (ICF) amendments. The trial was previously halted after a patient experienced a Suspected Unexpected Serious Adverse Reaction (SUSAR), leading to the implementation of liver monitoring and protocol adjustments to exclude patients with certain predispositions.

The clinical sites under the US central IRB have restarted their activities, with Inventiva anticipating a gradual resumption across other locations in the coming weeks. The company's focus on patient well-being is underscored by the recovery of the SUSAR patient. The NATiV3 trial, which is pivotal for NASH treatment, involves over 400 sites across 24 countries and aims to enroll approximately 900 patients for a 72-week treatment period. The trial's primary endpoints include the resolution of NASH and at least one stage of fibrosis improvement.

Inventiva's lead candidate, lanifibranor, is a PPAR agonist that targets all three peroxisome proliferator-activated receptor isoforms, offering a balanced activation profile. The FDA has recognized lanifibranor with Breakthrough Therapy and Fast Track designations for NASH treatment. The company, listed on Euronext Paris and Nasdaq, has a robust scientific team and an extensive library of pharmacologically relevant molecules, with a significant proprietary component.

The NATiV3 trial's topline results are expected in 2026, and the company is also advancing its pipeline with other preclinical programs. Inventiva's commitment to clinical development and regulatory approval is evident as it navigates the complexities of bringing new therapies to market for diseases with significant unmet needs.