Inventiva announces topline data from lanifibranor study

Inventiva announced topline results of the clinical study conducted by Kenneth Cusi from the University of Florida, evaluating lanifibranor in patients with NAFLD and type 2 diabetes mellitus, or T2D. The Phase II clinical trial randomized 38 patients into two arms, with patients receiving placebo or treatment with lanifibranor at 800mg/day for 24 weeks. The study achieved the primary efficacy endpoint with a 44% reduction of Intra Hepatic Triglycerides measured using proton magnetic resonance spectroscopy in patients with NAFLD and T2D treated with lanifibranor for 24 weeks compared to 12% in the placebo arm. This result is consistent with the Phase IIb NATIVE trial findings, in which lanifibranor demonstrated a statistically significant effect on steatosis reduction as measured by CAP/Fibroscan. The study demonstrated a statistically significant higher proportion of patients achieving a greater than 30% liver triglyceride reduction as well as NAFLD resolution defined as IHTG 5.5% at week 24, with lanifibranor compared to placebo. In addition, the study demonstrated a significant effect on a series of secondary endpoints including, glycemic control, atherogenic dyslipidemia, hepatic insulin action, insulin-stimulated muscle glucose disposal and amelioration of the adipose tissue dysfunction with a robust increase in plasma adiponectin. The treatment with lanifibranor 800mg/once daily for 24 weeks was well tolerated, with no safety concerns reported. Additional secondary endpoints including a series of markers of cardiometabolic health are anticipated to be presented by Cusi in upcoming scientific conferences and publications.