FDA Approves Phase 2 Trial of Lanifibranor in Patients with Diabetes, NAFLD

The first patient is anticipated to be enrolled in the third quarter of 2018, and topline results will be expected by the beginning of 2020.

The US Food and Drug Administration (FDA) has granted approval to Inventiva to proceed with a phase 2 trial of lanifibranor for patients with diabetes and concurrent nonalcoholic fatty liver disease (NAFLD).

Lanifibranor, an anti-fibrotic therapy, acts on a trio of alpha, gamma, and delta peroxisome proliferator-activated receptors (PPARs) which play a key role in the fibrotic process. The therapy is, according to Inventiva, seeking 2 potential indications, both of which pose a substantial unmet need: nonalcoholic steatohepatitis (NASH), a form of NALFD which affects more than 30 million in the United States, and systemic sclerosis, a condition with no approved therapies and a high mortality rate.

The study is set to be conducted by a team of investigators led by Kenneth Cusi, MD, FACP, FACE, the chief of the Division of Endocrinology, Diabetes, and Metabolism at the University of Florida, in Gainesville. It will seek to enroll 64 patients to be treated with a daily 800-mg dose of lanifibranor or placebo, as well as a group of 10 healthy, non-obese controls for comparison, over the course of 24 weeks.

The first patient is anticipated to be enrolled in the third quarter of 2018, and topline results will be expected by the beginning of 2020.

"With its unique pan-PPAR profile, lanifibranor has shown very good safety features, relevant efficacy data in NASH preclinical models as well as positive metabolic effects in a Phase IIa study in diabetic patients," Cusi said in a statement. "We anticipate the results of this study to translate well to diabetic patients with NAFLD or NASH and look forward to demonstrating that lanifibranor could become a very valuable drug for these patients."

The objective of the trial will be to measure metabolic improvements from baseline, and the impact of lanifibranor on steatosis in patients with type 2 diabetes and NAFLD. Imaging tech will be used to detect the therapy’s influence on fibrosis.

The primary endpoints will be the decrease in liver steatosis, the decrease in insulin resistance, and a decrease in de novo lipogenesis. Safety will also be assessed.

“We are delighted that the FDA has allowed Dr. Cusi and his team to proceed with this exciting metabolic and imaging study and we very much look forward to the enrollment of US patients as these results will provide additional supporting data for our regulatory filings with US and European regulators," Jean-Louis Abitbol, MD, MSC, the chief medical officer of Inventiva, said in a statement.