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Inventiva To Present The Results Of LEGEND Phase IIa Combination Trial With lanifibranor And Empagliflozin In Patients With MASH/NASH And T2D In An Investor Conference On Tuesday, March 19

Author: Benzinga Newsdesk | March 13, 2024 04:01pm

Inventiva (NASDAQ:IVA) (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), formerly known as NASH,  and other diseases with significant unmet medical needs, will hold an investor conference on Tuesday, March 19, to share the results of the LEGEND Phase II trial, a placebo-controlled, study evaluating lanifibranor alone and in combination with the SGLT2 inhibitor empagliflozin in patients with MASH/NASH and type 2 diabetes (T2D).  

Conference Call / Webcast Details

The Company will host a conference call and webcast, followed by a Q&A session, on Tuesday, March 19, 2024, at 8:00 am (New York), 1:00 pm (Paris). In order to participate to the conference call, please register at the following link: https://register.vevent.com/register/BI334d62953abb41cea27de99dc5da974c.

The live webcast will be available here and on the "Investor Presentations" page of the Inventiva website, with the recording and presentation available following the event.

About LEGEND

The 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, 24-week treatment, placebo-controlled 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 MASH/NASH and T2D. The diagnosis of non-cirrhotic MASH/NASH is based on historic histology evaluation or a combination of non-invasive methods including diagnostic methods including imaging.  The trial is double-blind for the placebo and lanifibranor arms and open-label for the combination of lanifibranor and empagliflozin arm. The results presented concern a pre-specified interim analysis on the first half of randomized patients, who have either completed the 24-week treatment period or prematurely discontinued from treatment earlier. The primary efficacy endpoint of the trial is the absolute change in Hemoglobin A1c (HbA1c) at week 24 compared to baseline. Secondary endpoints include changes in liver enzymes, markers of glucose and lipid metabolism, MRI-PDFF, markers of inflammation and fibrosis, body weight evolution and body fat composition.

About lanifibranor

Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce antifibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor ("PPAR") isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan-PPAR agonist in clinical development for the treatment of MASH/NASH. Inventiva believes that lanifibranor's moderate and balanced pan-PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre-clinical studies to date. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of MASH/NASH.

Posted In: IVA

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