NASH is a severe liver disease which affects 6-8% of adults in Western industrialized nations yet there is no approved treatment for patients available. NASH can lead to liver cirrhosis or liver cancer and treatment is urgently needed for those patients at highest risk of disease progression.
Lanifibranor has shown in clinical phase I and IIa studies that it is safe and efficacious. Its safety profile in those study was comparable to placebo. Equally, preclinical toxicology data in rodents and primates showed no safety concerns. Extensive efficacy studies in preclinical animal models demonstrate the potential of lanifibranor for the treatment of NASH.
Lanifibranor is currently being tested in a 24-week, placebo controlled, double blinded phase IIb study in patients with NASH. The purpose of this study is to evaluate the efficacy and the safety of two doses of lanifibranor for 24 weeks versus placebo in adult NASH patients with liver steatosis and moderate to severe necroinflammation without cirrhosis. The NATIVE trial is open and recruiting patients.