Inventiva S.A. announced positive topline results of the clinical study conducted by Dr. Kenneth Cusi from the University of Florida, evaluating lanifibranor in patients with NAFLD and type 2 diabetes mellitus (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 (IHTG) measured using proton magnetic resonance spectroscopy ((1) H-MRS) in patients with NAFLD and T2D treated with lanifibranor (800mg/daily) 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.(1) The study demonstrated a statistically significant higher proportion of patients achieving a greater than 30% liver triglyceride reduction (65% vs. 22%, p =0.008) as well as NAFLD resolution (25% vs. 0%, p = 0.048) 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 (reduction in hemoglobin A1c), atherogenic dyslipidemia (i.e., increase in HDL-C), hepatic
insulin action (i.e., fasting hepatic glucose production, hepatic insulin resistance index), insulin-stimulated muscle glucose disposal (i.e., in gold-standard euglycemic insulin clamp studies during high-dose insulin stimulation) 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 Dr. Cusi in upcoming scientific conferences and publications.