Results of LEGEND evaluating lanifibranor in combination with empagliflozin in MASH selected for oral presentation at the upcoming EASL SLD Summit 2025

Daix (France), New York City (New York, United States), January 22, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and other diseases with significant unmet medical needs, today announced that the results from its Proof-of-Concept trial evaluating lanifibranor in combination with empagliflozin for the treatment of MASH have been selected to be presented by Dr. Onno Holleboom in an oral plenary presentation at the upcoming Steatotic Liver Disease (SLD) Summit 2025 hosted by the European Association for the Study of the Liver (EASL) on January 23-25 in Estoril, Portugal.

The abstract evaluates the impact of combining lanifibranor with empagliflozin on metabolic improvements in patients with MASH and type-2 diabetes (T2D). The LEGEND trial, a multi-center, randomized, placebo-controlled Phase II Proof-of-Concept study, was designed to assess the safety and efficacy of lanifibranor (800mg/once daily) in combination with the SGLT2 inhibitor empagliflozin over a 24-week treatment period in patients with non-cirrhotic MASH and T2D.

The study met its primary efficacy endpoint, demonstrating a significant reduction in HbA1c levels in both the lanifibranor arm and the combination arm (lanifibranor with empagliflozin) compared to placebo. Furthermore, therapeutic efficacy with statistical significance was observed across multiple secondary endpoints, including markers of liver injury, glucose and lipid metabolism, and hepatic steatosis. The improvement in cardiometabolic and hepatic markers of MASH was similar in both active treatment groups. Of note, there was no weight gain in patients receiving the combination of lanifibranor and empagliflozin. The treatment with lanifibranor at a dosage of 800mg/once daily alone or in combination with empagliflozin was well tolerated, with no safety concerns reported.

The details of the presentation are as follows:

About Inventiva

Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH and other diseases with significant unmet medical need. The Company benefits from a strong expertise and experience in the field of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently advancing one clinical candidate, has a pipeline of two preclinical programs and continues to explore other development opportunities to add to its pipeline.

Inventiva’s lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with MASH, a common and progressive chronic liver disease.

Inventiva’s pipeline also includes odiparcil, a drug candidate for the treatment of adult MPS VI patients. As part of Inventiva’s decision to focus clinical efforts on the development of lanifibranor, it suspended its clinical efforts relating to odiparcil and is reviewing available options with respect to its potential further development. Inventiva is also in the process of selecting a candidate for its Hippo signaling pathway program.

The Company has a scientific team of approximately 90 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and clinical development. It owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly owned research and development facility.

Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA).

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This press release contains certain “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, forecasts and estimates with respect to Inventiva’s pre-clinical programs and clinical trials, including design, protocol, duration, timing, recruitment costs, screening and enrollment for those trials, including the ongoing NATiV3 Phase III clinical trial with lanifibranor in MASH and the LEGEND Phase II, Proof-of-Concept combination trial with lanifibranor and empagliflozin in patients with MASH and T2D, and the results and timing thereof and regulatory matters with respect thereto, clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits including reduction in HbA1c, reduction in hepatic steatosis, the effect on liver enzymes (ALT and AST), insulin resistance (HOMA-IR), HDL, adiponectin, liver inflammation and fibrosis, and reduction in the VAT/SAT ratio, of lanifibranor alone and in combination with empagliflozin in patients with MASH and T2D, of Inventiva’s product candidates, including lanifibranor alone and in combination with empagliflozin, the effect of lanifibranor alone and in combination with empagliflozin on the weight of the patients receiving treatment, the tolerability and safety profile of lanifibranor observed during trials, the potential of lanifibranor to address the specific metabolic unbalance in patients with T2D while also addressing steatosis and fibrosis, a hepatic consequence of insulin resistance, the estimated market size and patient population, potential regulatory submissions, approvals and commercialization, Inventiva’s pipeline and preclinical and clinical development plans, the potential development of and regulatory pathway for odiparcil, and future activities, expectations, plans, growth and prospects of Inventiva and its partners. 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