MediciNova updates investors on MN-001 trial and ALS program

what happened

MediciNova provided shareholders with an update on the 24-week randomized, double-blind, placebo-controlled study of MN-001 in 40 patients with nonalcoholic fatty liver disease and hypertriglyceridemia associated with type 2 diabetes mellitus, GlobeNewswire reported. The exploratory trial did not achieve statistical significance on its primary endpoints.

The company said MN-001 produced statistically significant improvements in high-density lipoprotein cholesterol and HDL particle concentration, along with an early statistically significant reduction in serum triglycerides. After 24 weeks, triglycerides, liver fat and body weight were also lower in the MN-001 group than in the placebo group, although those differences were not statistically significant. The treatment was well tolerated, with no drug-related serious adverse events reported. MediciNova is conducting additional analyses of the full dataset.

The company also said it had completed the Phase 2b/3 COMBAT-ALS trial of MN-166, or ibudilast, in 234 patients with amyotrophic lateral sclerosis. The primary endpoint is Combined Assessment of Function and Survival, and topline results remain expected by year-end. MN-166 has Fast Track and Orphan Drug designations from the FDA for ALS, as well as orphan designation in Europe.

why it matters

The MN-001 data support continued development but leave uncertainty around efficacy because the primary endpoints were not statistically significant. Investors will also be watching the expected year-end COMBAT-ALS topline results as the next major clinical update for MediciNova.

instruments