Lanifibranor Treatment NASH: FDA Awarded "Breakthrough Therapy Title"

Non-alcoholic fatty liver disease is a type of clinical-histological pathological disease that has histological characteristics similar to alcoholic liver damage, but is defined to occur in patients with little or no history of alcohol consumption.
Such diseases have a series of histological manifestations, the light of which is manifested as the accumulation of fat in liver cells that is not accompanied by inflammation or fibrosis, and the heavier of which manifests it as liver fat change accompanied by necrotizing inflammation, and may or may not be accompanied by fibrosis.
biopharmaceutical company Inventiva announced today that the U.S. Food and Drug Administration (FDA) has awarded lanifibranor, the company's leading drug candidate, a "breakthrough therapy" for the treatment of non-alcoholic fatty hepatitis (NASH).
lanifibranor is believed to be the first NASH treatment to receive the title since January 2015.
is a pan-PPAR agitant that reaches the primary and several critical secondary endpoints of the trial in Phase 2b clinical trials for the treatment of non-alcoholic fatty hepatitis (NASH).
FDA's Breakthrough Therapy Title is designed to accelerate the development and review of drug candidates for serious or life-threatening diseases.
in order to qualify, candidate drugs must show initial clinical efficacy, i.e. a substantial improvement over existing therapies or placebos (if not approved therapies).
in June 2020, the IIb Phase Clinical Trials, a 24-week clinical study, showed that lan ifibranor reached its primary endpoint, significantly reducing the Satosis Activity Fibrosis score (SAF).
addition, lanifibranor has reached critical secondary endpoints, including NASH subsidion, no deterioration of fibrosis and improvement of liver fibrosis.
NATIVE is a randomized double-blind, placebo-controlled Phase 2b clinical trial in which patients diagnosed with NASH were treated with two different doses of lanifibranor or placebo.
results showed that lanifibranor reached the primary endpoint of the 24-week clinical trial.
in patients receiving lanifibranor therapy (ITT) at a dose of 1200 mg/day, the SAF scores assessing inflammation of liver cells and hepatocellular ballooning were significantly lower than the baseline (while liver fibrosis did not worsen).
49 per cent of patients in the Lanifibranor treatment group (1200 mg/day) reached this endpoint, and the placebo group had a value of 27 per cent (p=0.004).
, Lanifibranor also reached several critical secondary endpoints, including achieving at least one level of improved fibrosis in the 1200 mg/day dose group while keeping NASH symptoms from worsening.
said it had decided to move the clinical research project to a critical Phase 3 clinical phase based on published top-line results.
the company will discuss with the FDA and the EMA to determine the design of relevant clinical trials.
also plans to report the results of the clinical trial at a medical conference in November.
, however, last year Lanifibranor failed in phase II clinical (IIb) of systemic sclerosis called FASST.
the experiment recruited 145 patients with diffuse skin systemic sclerosis ("dcSSc") to compare two doses of Lanifibranor, 400, 600 mg, and a placebo to an improvement in a skin index called msSS.
results were no different in the 48-Wednesday group of patients on the standard therapy background, and the trial missed all secondary endpoints.
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