Inventiva receives positive DMC recommendation for NATiV3 Phase 3 trial with lanifibranor in MASH patients

On November 30, 2024, Inventiva, a clinical-stage biopharmaceutical company listed on Euronext Paris and Nasdaq, announced a significant milestone in its ongoing Phase 3 clinical trial, NATiV3, for its lead product candidate, lanifibranor. The Data Monitoring Committee (DMC), an independent panel of experts, recommended continuing the clinical trial without any changes to the existing protocol. This recommendation was based on a thorough review of unblinded safety data from over 1,000 patients participating in the study.

The DMC's analysis revealed that more than 800 patients had been treated with lanifibranor for over 24 weeks, while another 177 patients had been on the medication for more than 72 weeks. This extensive safety data reaffirmed the drug's favorable safety and tolerability profile, prompting the committee to endorse the continuation of the trial without modifications.

Lanifibranor is an orally-administered small molecule designed to combat metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), along with other diseases that currently lack adequate treatment options. The drug functions as a pan-PPAR agonist, targeting all three isoforms of the peroxisome proliferator-activated receptors (PPARs)—PPARα, PPARδ, and PPARγ. These nuclear receptor proteins play a crucial role in regulating gene expression, and lanifibranor's balanced activation of these isoforms contributes to its anti-fibrotic, anti-inflammatory, and metabolic benefits.

Unlike other PPAR agonists that typically target only one or two of the PPAR isoforms, lanifibranor is unique in its comprehensive activation of all three. This balanced approach potentially contributes to its observed tolerability and efficacy, making it a promising candidate for the treatment of MASH. The U.S. Food and Drug Administration (FDA) has recognized lanifibranor's potential by granting it Breakthrough Therapy and Fast Track designations for MASH treatment.

Inventiva specializes in developing oral small molecule therapies aimed at treating MASH and other diseases with significant unmet medical needs. The company leverages its deep expertise in nuclear receptors, transcription factors, and epigenetic modulation to advance its drug candidates. In addition to lanifibranor, Inventiva’s pipeline includes odiparcil, a drug candidate for treating adult patients with MPS VI. Despite its focus on lanifibranor, the company is exploring further development options for odiparcil and continues to investigate new therapeutic avenues, including candidates targeting the Hippo signaling pathway.

With a team of roughly 90 scientific experts, Inventiva boasts extensive knowledge in biology, medicinal and computational chemistry, pharmacokinetics, pharmacology, and clinical development. The company also possesses an extensive library of approximately 240,000 pharmacologically relevant molecules, around 60% of which are proprietary. Inventiva's research and development operations are supported by a fully-owned facility.

Inventiva's listing on Euronext Paris and the Nasdaq Global Market underscores its commitment to advancing innovative treatments for challenging diseases. The company's progress with lanifibranor and its other pipeline projects highlights its potential to make a significant impact in the field of biopharmaceuticals.