HealthDay News — For patients with active nonalcoholic steatohepatitis (NASH), the percentage with a reduction in activity of steatohepatitis is significantly higher among those receiving 1200mg of lanifibranor once daily for 24 weeks compared with those receiving placebo, according to a study published in the October 21 issue of the New England Journal of Medicine.
Sven M. Francque, MD, PhD, from Antwerp University Hospital in Belgium, and colleagues randomly assigned 247 patients with noncirrhotic, highly active NASH in a 1:1:1 ratio to receive 1200mg or 800mg of lanifibranor or placebo once daily for 24 weeks in a phase 2b trial.
The researchers found that the percentage of patients with a decrease of at least 2 points in the activity part of the Steatosis, Activity, Fibrosis scoring system, without worsening of fibrosis, was significantly higher for those receiving 1200mg, but not for those receiving 800mg of lanifibranor vs placebo (55 vs 33% and 48 vs 33%, respectively). Both the 1200mg and 800mg doses of lanifibranor were favored over placebo for resolution of NASH without fibrosis worsening (49 and 39%, respectively, vs 22%), for improvement of at least 1 in fibrosis stage without NASH worsening (48 and 34%, respectively, vs 29%), and for resolution of NASH plus improvement of at least 1 in fibrosis stage (35 and 25%, respectively, vs 9%). In the lanifibranor groups, liver enzyme levels decreased and the levels of the majority of lipid, inflammatory, and fibrosis biomarkers improved.
“The next step in the regulatory pathway for lanifibranor is a phase 3, double-blind, randomized, placebo-controlled trial with clinical benefit as an end point,” write the authors of an accompanying editorial.
The study was funded by Inventiva Pharma, the manufacturer of lanifibranor.