Phase 2 trial of elafibranor for NAFLD liver lipid composition launches

Genfit initiated a phase 2 trial to evaluate the effect of elafibranor on hepatic lipid composition in patients with nonalcoholic fatty liver disease, according to a press release.

Additionally, a phase 3 trial is ongoing to investigate elafibranor for nonalcoholic steatohepatitis resolution without worsening of fibrosis.

“From Genfit’s 20 years of research, we have seen that the synergistic combination of PPAR alpha and delta results in a pleiotropic impact resulting in benefits for many of the characteristics of NAFL and NASH,” Dean Hum, PhD, chief operating officer and chief scientific officer of Genfit said in the release. “The significant benefit is due largely to the pluripotent effects on the disease cascade, including driving on-target liver directed activity at the hepatocyte level, providing increased oxidation of fatty acids, thereby reducing the injury to the liver.”

The previous phase 2b trial of elafibranor for NASH showed beneficial effects on cardiometabolic lipids, glucose metabolism, and a favorable safety and tolerability profile.

The upcoming randomized, controlled phase 2 trial will comprise 16 patients with NAFLD as identified with magnetic resonance spectroscopy. The primary objective is the effects of 120 g daily treatment for 6 weeks compared with placebo on changes in hepatic lipid composition. Secondary measurements include lipid metabolism, inflammatory markers, and liver function.

“The data Genfit will generate from this trial will be supportive for defining the relationship between different types of lipids and their roles,” Vlad Ratziu, MD, from the University Hospitals Pitié Salpêtrière in Paris, France, said in the release. “MRI-PDFF is an informative tool used to address fat quantity, but is still unable to differentiate between saturated and unsaturated fatty acids, all which produce different pathophysiological outcomes. This is why using H-MRS is important to gain precious insights on the quality of intrahepatic fat.”

Reference: www.genfit.com