Inventiva secures US$410M to advance MASH treatment

FRANCE—Inventiva has announced a substantial financing package totaling US$410 million to develop oral small molecule therapies for metabolic dysfunction-associated steatohepatitis (MASH) and other conditions with significant unmet medical needs.

In their statement, Inventiva indicated that €94.1 million (US$103.4 million) of the financing will be received immediately, with the remaining amount of up to €348 million (US$380 million) being  secured later, contingent upon meeting specified conditions.

This funding is earmarked to support the completion of the Phase 3 NATiV3 trial for MASH and prepare for the potential filing for marketing approval and subsequent commercialization of lanifibranor, the company’s lead candidate.

Moreover, the financing of €348 million (US$380 million) will be sourced through future issuance phases.

Inventiva has also secured an additional US$30 million through milestone payments related to an existing licensing and collaboration agreement with the Chinese pharmaceutical company CTTQ.

The financing transaction was led by prominent firms, including New Enterprise Associates, BVF Partners LP, and Samsara BioCapital, with participation from both existing and new investors.

As a result of this financing, Dr. Mark Pruzanski, who serves as the chairman of Corteria Pharmaceuticals and the biotech company Abcuro, will join Inventiva as chairman.

 Additionally, Srinivas Akkaraju, the founder of Samsara BioCapital, will take on a directorial role following the financing deal.

The board will also welcome four additional directors from the largest investors, with at least two replacing existing members.

The randomized, double-blind, placebo-controlled trial aims to evaluate the long-term efficacy and safety of lanifibranor in adults diagnosed with biopsy-proven, non-cirrhotic MASH and F2/F3 stage liver fibrosis.

 Approximately 1,000 patients are expected to participate across 494 study sites, as detailed in a listing on ClinicalTrials.gov.

The trial is back on track after recruitment was temporarily halted earlier this year due to a potential treatment-related serious adverse event.

The treatment landscape for MASH has gained increased attention this year, particularly after Madrigal Pharmaceuticals secured the first U.S. Food and Drug Administration (FDA) approval for Rezdiffra (resmetirom).

According to estimates from GlobalData, the MASH market is projected to reach US$25.7 billion in sales by 2032, encompassing seven major markets: the U.S., France, Germany, Italy, Spain, the UK, and Japan.

Lanifibranor, an orally administered small molecule, activates three peroxisome proliferator-activated receptor (PPAR) isoforms, which are critical in regulating key aspects of MASH, including inflammation, fibrosis, steatosis, and metabolism.

The compound has shown promising results in a Phase IIb trial, successfully meeting both primary and key secondary endpoints.

Frederic Cren, Inventiva’s CEO, expressed that this financing reflects the strong confidence of participating investors and their partner CTTQ in the transformative potential of lanifibranor for patients suffering from MASH.

He added that the total proceeds from this financing would be instrumental in supporting the MASH program, facilitating the subsequent filing for marketing approval, and preparing for lanifibranor’s potential commercialization.

Dr. Mark Pruzanski, the newly appointed Chairman of the Board at Inventiva, emphasized his longstanding belief in lanifibranor’s therapeutic potential for MASH and expressed his excitement about joining the company in this pivotal role.

 He highlighted that, based on results from the previously published Phase 2b NATIVE study, lanifibranor has the potential to be the “best in category” oral drug due to its insulin-sensitizing and direct antifibrotic benefits.

 This makes it an ideal therapy for the significant population of Type 2 diabetic patients with advanced fibrosis due to MASH who are at high risk of progressing to liver failure.

With the support of the announced funding, he looks forward to collaborating with Frederic and the rest of the board to enhance the company’s capacity to fulfill the promise of lanifibranor. 

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