(News Bulletin 247) – The company announced on Tuesday evening that lanifibranor had achieved its primary efficacy endpoint, namely a reduction in liver fat, in a phase II clinical study. The action jumped on the Paris Stock Exchange.

The news flow (or “newsflow” as our Anglo-Saxon colleagues say) is definitely promising for Inventiva. The Burgundian biotech had already been supported at the end of last month by obtaining, by its Chinese partner, Sino Biopharm, the authorizations necessary for the clinical development of its phase molecule, lanifibranor, in mainland China.

But this Tuesday’s announcement is of a different caliber. Inventiva has indicated that a phase II clinical trial (intermediate stage before phase III and then potential commercial authorization) evaluating lanifibranor has reached its primary efficacy endpoint.

Remember that this molecule is intended to treat non-alcoholic fatty liver disease, nicknamed “fatty liver disease”, which is characterized by an accumulation of fat in the liver, apart from any excessive consumption of alcohol. This disease is more common in people with type 2 diabetes.

fat reduction

“It is most often asymptomatic, but the accumulation of fatty acids can lead to an inflammatory response called non-alcoholic steatohepatitis which promotes the development of cirrhosis and in some cases the development of hepatocarcinoma (the most common liver tumor frequent)”, explains Inserm.

This phase II clinical study evaluated the efficacy of lanifibranor in patients with type 2 diabetes and non-alcoholic fatty liver disease (NAFLD), in a total of 38 patients. The study thus met its primary endpoint with a 44% reduction in intrahepatic triglycerides in patients with type 2 diabetes and non-alcoholic fatty liver disease with lanifibranor at a dose of 800 milligrams daily for 24 weeks, compared to 12% in the placebo group.

This study also demonstrated a significant effect on several secondary endpoints, in particular glycemic control or the elimination of muscle glucose stimulated by insulin.

“Treatment with lanifibranor 800 milligrams once daily was well tolerated and no safety concerns were reported,” the company also said.

“This is an important study for a drug candidate that has already shown promising results in patients with NASH (non-alcoholic steatohepatitis, editor’s note). Lanifibranor is a drug candidate with activity on resistance to insulin that has been shown to improve steatohepatitis and fibrosis,” said Professor Kenneth Cusi, head of the University of Florida’s Department of Endocrinology, Diabetes and Metabolism, and study investigator.

On the Paris Stock Exchange, the Inventiva title jumped 36% to 4.625 euros around 2:30 p.m., and even returned to the green (+3.3%) since January 1.