Inventiva announces that its IND application for the Phase II combination trial with lanifibranor and empagliflozin in patients with NASH and T2D has been accepted by the FDA
Related Deal leadKinam Hong
March 08, 2022 02:00 ET | Source: INVENTIVA
- FDA assessment concludes that the Phase II combination trial, LEGEND, may proceed
- The initiation of the trial is planned for H1 2022 and the publication of topline results is expected for H2 2023
Daix (France), Long Island City (New York, United States), March 8, 2022 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH) and other diseases with significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has completed its safety review of the IND application and has concluded that the proof-of-concept Phase II combination trial with its lead drug candidate lanifibranor and the SGLT2 inhibitor empagliflozin(1) in patients with Type 2 Diabetes (T2D) and non-cirrhotic NASH may proceed.
Pierre Broqua, Chief Scientist Officer and cofounder of Inventiva, stated: “The FDA’s decision to clear our Investigational New Drug submitted for our proof-of–concept study, LEGEND, is an important milestone for the development of lanifibranor. Our Phase IIb(2) has successfully demonstrated that lanifibranor as a monotherapy could not only resolve NASH and improve fibrosis but also improve the lipids and glycemic profiles. We believe that a combination therapy with lanifibranor and empagliflozin can provide additional benefits and further improve the cardiometabolic risk profile of patients with NASH.”
Dr. Onno Holleboom, Internist and endocrinologist at Amsterdam University Medical Centers and co-Principal Investigator of LEGEND: “As a pan-PPAR agonist acting on the key components of NASH: metabolism, inflammation and fibrosis, lanifibranor is a good candidate for a first-line pharmacology treatment for NASH. However, NASH is a multifaceted disease and the treatment of NASH will naturally evolve to include combination therapies in order to address the full cardiometabolic spectrum of the disease. Combination therapies allow to individualize treatment and improve clinical management of patients and I am excited to assess whether lanifibranor and empagliflozin could potentially lead to such results for patients with T2D and NASH.”
The planned Phase II trial, LEGEND(3), has been designed as a multi-center randomized, placebo-controlled proof-of-concept trial to assess the safety and efficacy of lanifibranor in combination with the SGLT2 inhibitor empagliflozin for the treatment of patients with non-cirrhotic NASH and T2D. The trial is double-blind for the placebo and lanifibranor arms and open-label for the combination of lanifibranor and empagliflozin arm.
LEGEND is expected to recruit a total of 63 patients non-cirrhotic NASH with T2D. The diagnosis of non-cirrhotic NASH will be based on historic histology evaluation or a combination of non-invasive methods including imaging and serum-based metabolic diagnostic tests.
The primary efficacy endpoint of the trial is a change in Hemoglobin A1c (HbA1c) at the end of the 24-week treatment compared to baseline. Secondary endpoints include changes in liver enzymes, glycaemic and lipids parameters, inflammatory markers and body fat composition. The trial is designed to provide valuable information on body weight evolution and body fat composition in patients with NASH and T2D when treated with lanifibranor and empagliflozin. Magnetic resonance imaging (MRI) will in addition allow to collect non-invasive data on hepatic fat, inflammation and fibrosis.
The initiation of the trial is planned for the first half of 2022 and the publication of top line results is expected for the second half of 2023.
Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of NASH and other diseases with significant unmet medical need. The Company benefits from a strong expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva’s lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies.
The Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases that resulted in the discovery of the drug candidate cedirogant (ABBV-157), an oral RORg inverse agonist which is being evaluated in a Phase IIb clinical trial, led by AbbVie, in adult patients with moderate to severe chronic plaque psoriasis. Inventiva’s pipeline also includes odiparcil, a drug candidate for the treatment of adult mucopolysaccharidoses (MPS) VI patients. As part of Inventiva’s decision to focus clinical efforts on the development of lanifibranor, it suspended clinical efforts relating to odiparcil and is reviewing available options with respect to its potential further development. Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program.
The Company has a scientific team of approximately 70 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 C of the regulated market of Euronext Paris (ticker: IVA - ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com.
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(1) Empagliflozin is marketed under the brand name Jardiance® by Boehringer Ingelheim and Eli Lilly and Company. Jardiance is approved for treating type 2 diabetes and reducing the risk of cardiovascular disease for adults with type 2 diabetes. Lilly reported Jardiance® global sales of $1.15 billion in 2020, while Boehringer posted worldwide Jardiance® sales of €2.48 billion. (Source: Eli Lilly and Boehringer Ingelheim 2020 annual reports).
(2) N Engl J Med 2021; 385:1547-1558.
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