MediciNova Inc (NASDAQ:MNOV) shares fell 14.7% in premarket trading on Monday after the company reported topline results from a Phase 2 clinical trial evaluating tipelukast, or MN-001, in patients with nonalcoholic fatty liver disease and hypertriglyceridemia associated with type 2 diabetes mellitus.
The MN-001-NATG-202 trial did not achieve statistical significance for its primary endpoints at Week 24.
MN-001 produced a statistically significant reduction in serum triglycerides at Week 4, but the difference was not maintained through the end of the 24-week treatment period.
Triglyceride Endpoint Does Not Reach Statistical Significance
The randomized, double-blind, placebo-controlled study enrolled 40 patients and included a 24-week treatment period.
At Week 24, mean serum triglycerides decreased by 45.8 mg/dL in the MN-001 group, compared with a decline of 14.4 mg/dL in the placebo group. The difference was not statistically significant, with a p-value of 0.113.
Liver fat, measured using the controlled attenuation parameter score, also showed a numerical difference between the treatment and placebo groups that did not reach statistical significance.
Mean CAP scores decreased by 14.1 dB/m among patients receiving MN-001, compared with a decline of 4.3 dB/m in the placebo group, with a p-value of 0.2438.
HDL Measures Show Statistically Significant Differences
The study reported statistically significant differences in HDL cholesterol and HDL particle concentration.
Mean HDL-C increased by 3.3 mg/dL in the MN-001 group and decreased by 2.4 mg/dL in the placebo group, with a p-value of 0.0048.
Mean HDL particle concentration increased by 3.62 µmol/L in the treatment group, compared with a decrease of 0.9 µmol/L among patients receiving placebo. The difference had a p-value of 0.018.
Body weight declined by an average of 4.91 pounds in the MN-001 group and by 0.55 pounds in the placebo group. The difference was not statistically significant, with a p-value of 0.082.
MediciNova to Assess Next Development Stage
MediciNova reported no drug-related serious adverse events during the study.
The company plans to continue analysing the trial data and assess the next stage of clinical development for MN-001, including the patient population and sample size for potential future studies.
The source material did not provide a timetable for a subsequent clinical trial.
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