Inventiva Secures €348 Million to Advance Phase 3 MASH Study of Lanifibranor
Key Insights
Inventiva has secured €94.1 million in equity financing, part of a larger €348 million transaction, to advance its Phase 3 NATiV3 clinical trial for MASH (search).
The NATiV3 study is evaluating lanifibranor in over 1,100 patients with noncirrhotic MASH (search), with enrollment completion projected in the first half of 2025.
The financing includes up to $30 million in milestone payments from CTTQ (search) and will support the MASH (search) program, marketing approval filings, and potential commercialization of lanifibranor.
Inventiva, a clinical-stage biopharmaceutical company, has announced a financing agreement of up to €348 million to support the advancement of its Phase 3 NATiV3 clinical trial. The study is evaluating lanifibranor, an oral small molecule therapy, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH (search)). The financing aims to fund the completion of the trial, preparation for potential marketing approval, and commercialization of lanifibranor.
The transaction, led by New Enterprise Associates, BVF Partners LP, and Samsara BioCapital, includes an immediate €94.1 million and potential milestone payments. More than 1,100 patients have been randomized in the NATiV3 study, with completion of enrollment projected in the first half of 2025. The company also announced the appointment of Mark Pruzanski, MD, as Chairman and Srinivas Akkaraju, MD, PhD, as a director, subject to shareholder approval.
Lanifibranor's Potential in MASH Treatment
Lanifibranor is designed to induce antifibrotic, anti-inflammatory, and beneficial metabolic changes by activating all three peroxisome proliferator-activated receptor (PPAR (search)) isoforms. Dr. Mark Pruzanski highlighted the potential of lanifibranor as a 'best in category' oral drug, particularly for type 2 diabetic patients with advanced fibrosis (search) due to MASH (search).
Dr. Nezam Afdhal from Harvard Medical School noted the excitement among investigators and clinicians regarding lanifibranor's potential to improve both fibrosis (search) and resolution of MASH (search), along with improving metabolic profiles and cardiovascular risk factors.
Transaction Details and Use of Proceeds
The financing consists of multiple phases, including the issuance of new ordinary shares and warrants. The proceeds will primarily fund the NATiV3 clinical program and preparations for regulatory submissions. Inventiva intends to use approximately 85% of the net proceeds for the NATiV3 program and the remainder for general corporate purposes.
Ongoing Clinical Development
Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase 3 clinical trial, NATiV3, for the treatment of adult patients with MASH (search), a common and progressive chronic liver disease. The company anticipates topline results from the NATiV3 trial in the second half of 2026.
LEGEND Trial Abstract Accepted for AASLD Liver Meeting
Inventiva also announced that a late-breaker abstract from the LEGEND Phase 2 trial, evaluating lanifibranor in combination with empagliflozin in MASH (search) patients with type 2 diabetes, has been accepted for presentation at The Liver Meeting® 2024. The poster presentation will detail the metabolic improvements observed with the combination therapy.