Inventiva SA (NASDAQ:IVA) announced the topline results of Phase 2 clinical study evaluating lanifibranor in patients with NAFLD and type 2 diabetes mellitus.
The study achieved the primary efficacy endpoint with a 44% reduction of Intra Hepatic Triglycerides (fat in the bloodstream) compared to 12% in the placebo arm.
This result is consistent with the Phase 2b NATIVE trial findings, in which lanifibranor demonstrated a statistically significant effect on steatosis reduction as measured by CAP/Fibroscan.
Related: Inventiva To Change Clinical Development of Its Lead NASH Candidate.
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.
Lanifibranor treatment significantly improved both hepatic and peripheral insulin sensitivity (i.e., fasting plasma insulin, fasting hepatic glucose production, hepatic insulin resistance index, insulin-stimulated muscle glucose disposal), which translated into better glycemic control (i.e., HbA1c).
The study met multiple secondary metabolic endpoints confirming the cardiometabolic benefit of lanifibranor in patients.
The study confirmed the favorable safety and tolerability profile of lanifibranor.
Price Action: IVA shares are up 26.40% at $4.64 during the premarket session on the last check Wednesday.
