Benzinga | Oct 27, 2021 04:28PM EDT

Inventiva Announces Design Of LEGEND Phase IIa Combination Trial With lanifibranor And SGLT2 Inhibitor Empagliflozin In Patients With NASH And Type 2 Diabetes

* The LEGEND trial is a proof-of-concept Phase IIa clinical trial to evaluate the safety and efficacy of lanifibranor in combination with the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance(r)1) in patients with non-alcoholic steatohepatitis (NASH) and type 2 diabetes (T2D)

* The trial will be conducted in several sites in the United States and Europe with a treatment duration of 24 weeks, and a total enrollment target of 63 patients with T2D and non-cirrhotic NASH

* 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), October 27, 2021 -- Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, mucopolysaccharidoses (MPS) and other diseases with significant unmet medical needs, today announced the design of a proof-of-concept

Phase IIa combination trial with its lead drug candidate lanifibranor and the SGLT2 inhibitor empagliflozin in patients with T2D and non-cirrhotic NASH.

LEGEND (Lanifibranor in combination with the SGLT2 inhibitor empagliflozin in patients with NASH and type 2 diabetes ) trial has been designed as a multi-center randomized, placebo-controlled proof-of-concept Phase IIa 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.

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.

A total of 63 patients with non-cirrhotic NASH and T2D will be randomized into the trial, in several sites in the United States and Europe. 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 ("probable NASH"). 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.

Pierre Broqua, Chief Scientist Officer and cofounder of Inventiva, stated: "We are delighted to announce the design of our proof-of-concept trial to evaluate the combination therapy of lanifibranor and empagliflozin. Given the complexity of NASH, the heterogeneity of patients and the results of our Phase IIb trial with lanifibranor in NASH, it is possible that a combination with empagliflozin could further improve the therapeutic effects of lanifibranor on markers of cardiometabolic health."

The LEGEND trial will also be part of a dedicated Key Opinion Leader (KOL) webcast focused on NASH and hosted by Inventiva on November 19, 2021 on the sidelines of the AASLD The Liver Meeting(r) 2021. This event can be followed both live and on-demand on Inventiva's website in the "Investors -- Investor Presentations" section at: http://inventivapharma.com/investors/investor-presentations/.