An unexpected new contender in the race to develop a treatment for NASH (non-alcoholic steatohepatitis) emerged from a European medical conference on Thursday morning – the drug giant Novo Nordisk (NVO).
In a small European study, almost 40% of patients receiving Novo’s blockbuster diabetes drug Victoza (liraglutide) had complete resolution of NASH at the end of a year-long study, compared to just 9% of patients receiving a placebo.
At the 50th International Liver Congress on Thursday, a researcher from the University of Birmingham presented results from the LEAN study, testing liraglutide for 48 weeks in overweight patients with biopsy-proven NASH. 52 patients were randomly assigned to treatment with once-daily injection of either 1.8mg of liraglutide or a placebo. The study’s primary endpoint was the resolution of NASH and no worsening in fibrosis from baseline to end-of-treatment. Of the 45 patients who underwent liver biopsy at the end of study, 39% (9/23) who received liraglutide had resolved NASH with no worsening of fibrosis, compared to 9% (2/22) of patients receiving the placebo. 82.6% of patients showed improvement in fat content of the liver, and just two patients who received liraglutide had worsening of fibrosis compared to eight patients in the control arm.
Liraglutide is a long-acting glucagon-like peptide-1 receptor agonist already approved for Type 2 Diabetes, and more recently for the treatment of obesity in the U.S. (marketed as Saxenda).
The news puts competing NASH drug developers like Intercept Pharmaceuticals (ICPT) and Genfit (GNFT) on notice. Liraglutide has a clean safety profile and is recognized by practitioners as a go-to product. Though by the same token, there’s reason to believe that a drug like ICPT’s obeticholic acid could be used in tandem.
Additional data from Intercept’s own phase 2 FLINT study were available at the conference on Thursday.
