Inventiva, a clinical-stage biopharmaceutical company, announced the progression of its Phase III clinical trial, NATiV3, evaluating lanifibranor for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH). The trial has achieved over 85% of its targeted enrollment in the main cohort, with statistical powering expected to be superior to 95% for both doses evaluated.
The NATiV3 trial is currently screening patients at 359 sites across 24 countries. As of the latest update, 837 patients have been randomized in the main cohort, surpassing 85% of the targeted enrollment. Additionally, 296 patients have been randomized in the exploratory cohort, exceeding the original target of 200 patients. The United States accounts for 61% of the patients randomized.
Patient Characteristics and Biomarker Evolution
Baseline characteristics of patients randomized in the main cohort of NATiV3 are consistent with those observed in the Phase IIb NATIVE clinical trial. Notably, 13% of patients enrolled in the main cohort were on a stable dose of GLP-1 receptor agonist at baseline, potentially providing insights into the benefits of combining this class of products with lanifibranor.
A power analysis conducted in September 2024, assuming a response rate on the primary endpoint based on Phase IIb NATIVE results, confirmed that the study is well-powered, with both doses expected to exceed 95% statistical power. Blinded analyses, including 545 patients at week 24 and 119 patients at week 72, indicated a positive evolution of hepatic, lipid, glycemic, and fibrosis markers, as well as Fibroscan scores, comparable to the NATIVE Phase IIb study results. This suggests that lanifibranor is having the expected benefits in NATiV3 patients. The blinded analysis also showed a similar weight gain pattern to that observed in the NATIVE Phase IIb trial, with weight gain plateauing and stabilizing after 24 to 36 weeks of treatment.
Financial Update and Future Milestones
Inventiva reported cash and cash equivalents of €10.1 million as of June 30, 2024. On July 18, 2024, the company issued royalty certificates subscribed by Samsara BioCapital and existing shareholders for €20.1 million, extending the cash runway until mid-October 2024. The company is actively reviewing potential financing and discussing strategic options with financial advisors and potential counterparties.
"We are actively engaged in discussions seeking additional financing with the goal of funding the Company through the anticipated Phase III topline results," stated Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva. "We believe the recent €20.1 million royalty deal, subscribed by Samsara BioCapital and longstanding shareholders such as BVF Partners, NEA, Sofinnova, and Yiheng, is a powerful endorsement of our strategy."
Last patient randomization is anticipated in the first half of 2025, with topline results expected in the second half of 2026.
