Inventiva SA ( IVA ) announced the publication in the peer-reviewed scientific journal Nature Communications of additional results from its NATIVE Phase 2b trial demonstrating the improvement of markers of cardiometabolic health in patients with MASH/NASH treated with lanifibranor.

Following lanifibranor treatment, the trial demonstrated significant improvement in patients with metabolic dysfunction-associated steatohepatitis (MASH)/ non-alcoholic steatohepatitis (NASH) with and without Type 2 Diabetes and with or without obesity of markers of cardiometabolic health.

In February, Inventiva ( IVA ) announced it stopped enrolling new patients in the NATiV3 Phase 3 trial for lanifibranor in NASH due to a reported serious adverse reaction. This reaction involved elevated liver enzymes in a patient undergoing treatment.

Lanifibranor treatment also led to lower fasting glucose to normal levels in 71% of patients with MASH/NASH and prediabetes treated with the 1200mg dose and 67% of patients treated with the 800mg dose versus 11% of patients on placebo.

In addition, no patients treated with either dose of lanifibranor with MASH/NASH and normoglycemia at baseline progressed to prediabetes at week 24, versus 26% of patients in the placebo arm.

Furthermore, 38% and 44% of patients with MASH/NASH and high cardiovascular risk treated with 1200mg and 800mg of lanifibranor, respectively, improved to intermediate or low cardiovascular risk at week 24.

44% and 35% of patients at intermediate risk improved to low risk when treated with 1200mg and 800mg of lanifibranor, respectively. However, in the placebo arm, only 26% of patients at high cardiovascular risk improved to intermediate, .2q   and 13% improved from intermediate to low cardiovascular risk.

The weight gain observed in a portion of the patient population treated with lanifibranor was shown to be associated with improvement of all markers of cardiometabolic health, similarly to patients treated with lanifibranor who maintained a stable weight throughout the study. 

This finding contrasts the weight gain observed in patients on placebo, which was associated with worsening cardiometabolic markers. 

In addition, the increase in adiponectin (helps insulin sensitivity and inflammation) levels following treatment with 1200mg and 800mg of lanifibranor occurred in 95% and 86% of patients, respectively, versus only 10% of patients in the placebo arm. 

The increase in adiponectin level at week 24 was correlated with improvement of markers of insulin resistance, glycemic control, lipid metabolism, and steatosis, as well as hs-CRP, aminotransferases, and improvement in liver histological endpoints for disease activity and fibrosis.

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