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Inventiva announced that, following a consultation with the FDA, Inventiva has decided to modify the clinical development plan of lanifibranor for the treatment of NASH. Inventiva's request for a consultation with the FDA followed a public communication by the FDA suggesting that an alternative approach to seek full approval in patients with NASH could be considered upon submission of results of a Phase III trial using a histology surrogate endpoint in patients with NASH and a Phase III clinical outcome trial in patients with NASH and compensated cirrhosis. The company's proposed changes to the NATiV3 trial are designed to align with the alternative regulatory approach and are expected to be beneficial to the overall lanifibranor clinical program by 1) reducing the number of biopsies a patient undergoes during the trial from three to two, 2) reducing the trial duration a patient has to consent to from 7 years to 72 weeks, 3) offering all patients in the trial access to a lanifibranor treatment for at least 48 weeks by allowing them to enter into a new active treatment extension study, and 4) potentially expanding the addressable patient population to include patients with NASH and compensated cirrhosis. The company continues to anticipate submission of a new drug application to the FDA for accelerated approval with such planned submission based on liver histological endpoints of approximately 900 patients treated over a 72-week period. A placebo-controlled exploratory cohort is anticipated to be added in parallel to Part 1 of the NATiV3 trial and will include approximately 200 patients with NASH and fibrosis who are not eligible for Part 1. The Company anticipates that this exploratory cohort may allow the generation of additional results using non-invasive tests and contribute to the safety database requirement to support the planned submission for potential accelerated approval. Under the newly planned trial design, the original Part 2 of the NATiV3 trial, a clinical outcome trial that was previously planned to be conducted in approximately 2,000 patients with F2 and F3 fibrosis for a maximum period of seven years will be replaced by a placebo-controlled Phase III outcome trial which will be event driven and is expected to last approximately three years. The Phase III outcome trial is expected to randomize approximately 800 patients with NASH and compensated cirrhosis. If the results of the outcome trial in patients with NASH and compensated cirrhosis are positive, the company anticipates they will support the submission of an NDA to the FDA for full approval and the potential expansion of the addressable patient population beyond patients with F2 and F3 fibrosis to include patients with NASH and compensated cirrhosis, a patient population at an increased risk of liver-related morbidity and mortality and for which the anti-fibrotic properties of lanifibranor could potentially prevent worsening of the disease. Lanifibranor has been granted both Fast Track and Breakthrough Therapy designations for the treatment of NASH, and the FDA confirmed last year that the Fast Track designation is also applicable to the treatment of NASH for patients with compensated cirrhosis. The Company does not expect these trial design changes to have a significant impact on the funds originally anticipated to be needed to potentially secure accelerated approval in the U.S. or conditional approval in the EU based on the new trial design.

Fortress Biotech (FBIO) announced that Lucy Lu, M.D., has been appointed to its Board of Directors. Dr. Lu is an accomplished executive with over 20 years of experience in a wide range of financial and drug development matters in the biotech and healthcare sectors as an investment banker, equity research analyst and executive at several biotech companies. Since April of 2022, Dr. Lu has served as Chief Operating Officer of Innovative Cellular Therapeutics. Additionally, she is currently a member of the Board of Directors of Inventiva (IVA).

Inventiva announced that the United States Patent and Trademark Office, or USPTO, granted a patent that protects the use of lanifibranor for the treatment of cirrhotic patients at risk of progressing from compensated stage to decompensated stage. This patent will expire on November 8, 2039. The company said, "This new patent further strengthens Inventiva's patent portfolio for lanifibranor, the company's lead product candidate, in the United States, which already comprised patents protecting the use of lanifibranor to treat several diseases including non-alcoholic steatohepatitis and fibrotic diseases. This patent further expands the intellectual property protection of lanifibranor in the United States for use in patients with cirrhotic NASH."