Commentary
The New England Journal of Medicine has published the results of the NATIVE Phase IIb clinical trial with lanifibranor in NASH. Lanifibranor met both the primary and key secondary endpoints, including NASH resolution with no worsening of fibrosis and improvement of liver fibrosis with no worsening of NASH.
The next step in the regulatory pathway for lanifibranor is NATiV3 trial, a phase 3, double-blind, randomised, placebo-controlled trial with clinical benefit as an end point, to assess whether longer treatment would result in similar efficacy.
According to the FDA, the study population would comprise patients with NASH with stage F2 or F3 fibrosis. Clinical benefit would consist of “delaying progression to a composite endpoint including histological progression to F4, hepatic decompensation events, change in MELD score, liver transplant and all-cause mortality.”
