Treatment of NASH pan-PPAR agonists reaches multiple stage 2b clinical endpoints

Inventiva has announced that its pan-PPAR agonisant, lanifibranor, has reached the primary and several critical secondary endpoints of the trial in a Phase 2b clinical trial for the treatment of non-alcoholic fatty hepatitis (NASH)According to the press release, this is currently the only research-in-therapy that meets both the FDA and the European Union's EMA for accelerating NASH drug approvalsNASH is a progressive liver disease caused by excessive accumulation of fat in the liver, which can lead to chronic inflammation of the liver, trigger progressive liver fibrosis, cirrhosis, and eventually lead to liver failure, cancer and deathLiver-related mortality increased significantly in patients with advanced fibrosisTo speed up the development of treatment sis therapy, the FDA issued new guidelines for drug development in 2018, noting that when developing NASH innovative therapies, liver histology endpoints can be used in clinical trials, and the two heliological endpoints identified by the FDA are:1The symptoms of fatty hepatitis are alleviated, while the degree of liver fibrosis does not worsen2The degree of liver fibrosis was eased, while the symptoms of fatty hepatitis did not worsenLanifibranor is a pan-PPAR agoniser in clinical development that produces balanced activation of PPAR alpha and PPAR, and is able to partially activate PPARIt can improve the symptoms of PATIENTs with NASH through a variety of mechanismsNATIVE 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 placeboThe results showed that in the 24-week clinical trial, lanifibranor reached the primary endpoint of the trialIn the group of patients receiving the intentional treatment (ITT) at a dose of 1200 mg/day, the SAF score assessed for hepatocellular inflammation and hepatocellular ballooning was significantly reduced compared to the baseline (while the degree of hepatic fibrosis did not deteriorate)49% of patients in the Lanifibranor treatment group (1200 mg/day) reached this end point, while the number in the placebo group was 27% (p-0.004)at the same time, lanifibranor also reached several critical secondary endpoints, including at least one level of improved fibrosis in the 1200 mg/day dose group while keeping NASH symptoms from worseningInventiva said it had decided to move the clinical research program to a critical Phase 3 clinical phase based on published top-line results The company will discuss with the FDA and EMA to determine the design of the relevant clinical trials Inventiva also plans to report the results of the clinical trial at a medical meeting in November