MediciNova stock tumbles on mixed Phase 2 NAFLD trial data

Investing.com -- MediciNova Inc (NASDAQ: MNOV) shares fell 14.7% in premarket trading Monday following mixed results from a Phase 2 clinical trial evaluating tipelukast (MN-001) for the treatment of nonalcoholic fatty liver disease and hypertriglyceridemia associated with type 2 diabetes mellitus.

The randomized, double-blind, placebo-controlled study enrolled 40 patients with a treatment period of 24 weeks. At Week 24, mean serum triglycerides decreased by 45.8 mg/dL in the MN-001 group compared to 14.4 mg/dL in the placebo group, but the difference was not statistically significant (p=0.113).

The trial did show statistically significant improvements in HDL cholesterol and HDL particle concentration. Mean HDL-C increased by 3.3 mg/dL in the MN-001 group while decreasing by 2.4 mg/dL in the placebo group (p=0.0048). Mean HDL-P increased by 3.62 µmol/L in the treatment group versus a decrease of 0.9 µmol/L in placebo (p=0.018).

Liver fat, measured by controlled attenuation parameter score, showed a numerical trend toward improvement but did not reach statistical significance. The mean CAP score decreased by 14.1 dB/m in the MN-001 group compared to 4.3 dB/m in placebo (p=0.2438). Body weight decreased by 4.91 lb in the treatment group versus 0.55 lb in placebo, though this difference was not statistically significant (p=0.082).

MN-001 demonstrated a generally favorable safety profile with no drug-related serious adverse events reported. The company stated it will continue detailed analyses and assess the next stage of clinical development, including appropriate patient population and sample size for future studies.

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