Inventiva Completes 1,009-Patient Phase 3 MASH Enrollment, Top-Line Data in H2
Inventiva’s phase 3 NATiV3 trial of lanifibranor in F2/F3 MASH is fully enrolled with 1,009 registrational and ~400 exploratory patients, and data cleaning is underway ahead of a H2 top-line readout. The company has cash runway to Q3 2027 assuming positive results and a €118 million financing tranche.
1. Enrollment Completion and Timeline
Inventiva’s phase 3 NATiV3 trial for MASH is now fully enrolled with 1,009 patients in the registrational cohort and approximately 400 exploratory patients. Data cleaning is underway ahead of database lock, with top-line lanifibranor results expected in the second half of 2026.
2. Cash Runway and Financing
Management projects cash runway through Q3 2027 contingent on positive phase 3 outcomes and a €118 million financing tranche. Recent October 2024 recapitalization extended financial resources, positioning Inventiva to self-launch lanifibranor if results support regulatory filing.
3. Trial Design and Endpoints
NATiV3 randomizes patients 1:1:1 across placebo, 800 mg, and 1,200 mg daily doses over 18 months, assessing dual primary endpoints of fibrosis stage improvement and steatosis reduction. The trial excludes F1 patients, includes around 60% diabetic subjects, and allows background GLP-1 or SGLT2 therapy.
4. Market Potential and Competitive Positioning
Lanifibranor targets an addressable F2/F3 U.S. population of about 375,000 patients, with stage 2 and 3 disease segments valued at over $1 billion. Phase 2b data showed 18% fibrosis reduction and HbA1c benefits, potentially positioning it against resmetirom, especially in diabetic and F3 patients.