Phase 2 Study (Lanifibranor) on Non-Alcoholic Fatty Liver Disease Commences

On Wednesday, Inventiva announced its selection of lanifibranor for a Phase 2 investigator-initiated clinical trial for a possible treatment for patients with non-alcoholic fatty liver disease in patients with type 2 diabetes (T2DM).

The study will be conducted by Kenneth Cusi, MD, Chief of the Division of Endocrinology, Diabetes & Metabolism in the Department of Medicine at the University of Florida, Gainesville, and is intended to evaluate the efficacy and safety of lanifibranor on intrahepatic triglycerides and hepatic insulin sensitivity in type 2 diabetic patients with nonalcoholic fatty liver disease (NAFLD).

Should the study yield positive results, lanifibranor would be reinforced as the ideal drug for NAFLD and NASH patients with T2DM.

Lanifibranor is a new generation panPPAR agonist that activates the alpha, gamma and delta isoforms of the peroxisome proliferator-activated receptors (PPARs). It was selected for the study because it can potentially address all key features of NAFLD and NASH—improvement of insulin-sensitivity, steatosis reduction, anti-inflammatory activity and reduction of fibrosis.

Enrollment is expected to contain 64 patients for a 24-week period with a single daily dose of lanifibranor (800mg/day) and 10 subjects in a healthy, non-obese control group. The measurement of the metabolic effects of lanifibranor, and its potential efficacy on steatosis in T2DM patients with NAFLD is the study’s overall objective.

A decrease of liver steatosis assessed by state-of-the-art imaging, including H-MRS (Proton Magnetic Resonance Spectroscopy), evidence of metabolic improvements in insulin resistance (glucose clamp, HBA1c), de novo lipogenesis, free fatty acids, lipids, and safety are the study’s main endpoints. In addition, by using the most recent imaging technology, lanifibranor’s impact on fibrosis will be detected.

“We are delighted that Dr Cusi, a renowned expert in the PPAR field and world-class clinician has selected lanifibranor for this study that will provide us with additional supportive data for our regulatory filings of lanifibranor with US and European regulators," said Jean-Louis Abitbol, MD, MSC, Chief Medical Officer of Inventiva. ¹

In explaining the significance of the study, Dr Cusi said, “PPARs are clinically validated targets to treat patients suffering from NAFLD or NASH. Lanifibranor with its moderate and balanced panPPAR profile and its gamma activity, is a very promising candidate addressing most if not all the components of NASH. We anticipate this profile will translate well into type 2 diabetic patients affected by NAFLD or NASH and are confident in the success of this trial."

Depending on the FDA approval of lanifibranor IND filing, the trial is expected to begin in Q2/Q3 2018. Alongside this investigator-initiated study, Inventiva is also currently conducting 2 lanifibranor Phase IIb clinical trials in NASH and SSc.

Inventiva is a biopharmaceutical company that develops innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc), and mucopolysaccharidosis,

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References:

1. “INVENTIVA Announces a U.S. Phase II Investigator-Initiated Study with Lanifibranor on Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes.” GlobeNewswire. 4 Apr. 2018