Inventiva announced the completion of patient enrollment in its pivotal Phase 3 NATiV3 clinical trial, with the randomization of the last patient in the main cohort on April 1, 2025. The company exceeded its original targets, enrolling 1,009 patients in the main cohort and 410 patients in an exploratory cohort.
This achievement marks a significant milestone in the development of lanifibranor, Inventiva's lead product candidate for the treatment of MASH and advanced fibrosis. Topline results from the NATiV3 trial are anticipated in the second half of 2026, which could position lanifibranor as the next oral therapy approved for MASH.
The completion of enrollment also satisfies key conditions for the issuance of the second tranche of Inventiva's structured financing, amounting to approximately €116 million. These conditions included the randomization of the last patient in the main cohort before April 30, 2025, and a study discontinuation rate of less than 30% before week 72.
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