Inventiva at Stifel cardiometabolic forum: lanifibranor nears key test

On Wednesday, 30 September 2026, Inventiva (IVA) utilized the Stifel 2026 Virtual Cardiometabolic Forum to emphasize its assertion that lanifibranor could potentially become a unique oral treatment for MASH, while also recognizing the primary risk: the ability of Phase III data to mirror earlier results. The management disclosed that the company has fully enrolled in the NATiV3 study and anticipates presenting top-line results during Q4 2026, a revelation that may influence both the drug's future and the company's financial strategy.

Inventiva reported that the NATiV3 study is fully enrolled, with the last patient visits concluded, and top-line data expected in the fourth quarter of 2026. The company highlighted Phase IIb NATIVE results showcasing an 18% placebo-adjusted reduction in fibrosis, 26% resolution of MASH, and 24% improvement on a composite endpoint combining both outcomes.

Management clarified that lanifibranor is designed to target both liver and metabolic factors contributing to MASH by exerting balanced activity across all three PPAR isoforms. Inventiva intends to self-commercialize lanifibranor, while remaining open to potential acquisition interest. The upcoming NATiV3 results are described as a crucial turning point.

This study, which enrolled over 1,000 patients, is designed to evaluate lanifibranor in a population that management believes closely mirrors the Phase IIb cohort from the initial NATIVE trial. The trial is completely enrolled, but the last patient visits have not yet been completed, and database lock has not occurred. Management did not provide a timeline for the lock.

Exploratory cohort data from F1 and F4 patients might not be prominently featured in the primary results. In a deliberate effort to construct NATiV3 conservatively, management utilized a higher assumption for placebo response and a lower estimate for drug effect than what was observed in Phase II. Additionally, the study was over-enrolled to account for patient terminations.

Management frequently referenced the Phase IIb NATIVE trial as the benchmark that NATiV3 must meet. In that trial, lanifibranor achieved an 18% placebo-adjusted improvement in fibrosis after six months, 26% resolution of MASH, and a 24% improvement on the composite endpoint that combined both fibrosis reduction and MASH resolution.

Campagna emphasized that the goal is not to surpass these numbers but to replicate them. He described the Phase II results as exceptionally strong, noting that there were eight times more responders on lanifibranor compared to placebo. He added that even if the Phase III effect is somewhat diminished, it should still retain significance.

The company also highlighted that the Phase II results were obtained within six months, indicating a faster histological change in fibrosis than previously observed in the field. Inventiva presented lanifibranor as a balanced, partial agonist across all three PPAR isoforms: alpha, delta, and gamma. The drug's design aims to address both liver and extrahepatic disease drivers in MASH.

Campagna explained that the drug was developed to circumvent some of the tolerability issues that affected earlier PPAR programs. He noted that the gamma component is intentionally partial, which should mitigate the downstream side effects associated with full gamma agonism. The balanced activity across PPAR alpha, delta, and gamma represents a key differentiator, as it is intended to limit tolerability concerns experienced with older drugs in this class.