MN-001 Hits Statistically Significant HDL-C and HDL-P Boosts in Phase 2 NAFLD Trial
MNOV has more than doubled off its 52-week low of $1.168.
Summary
MediciNova reported topline data from its Phase 2 trial of MN-001 (tipelukast) in NAFLD with hypertriglyceridemia and type 2 diabetes. The drug showed statistically significant increases in HDL-C (p=0.0048) and HDL-P (p=0.018) versus placebo at 24 weeks, plus a significant early triglyceride reduction at week 4 (p=0.015). Liver fat and body weight improved numerically but missed significance. Safety was clean with no drug-related SAEs. This is a proof-of-concept study in 40 patients, so the company plans a larger trial. The HDL effects are the strongest signal and could support a cardiovascular/metabolic development path. The stock is a micro-cap (~$127M), so positive Phase 2 data can move it sharply. Next catalyst would be detailed analyses and design of the next study.
Updates
· Benzinga — Shares fell 26.36% to $2.36 after the data. At week 24, triglycerides dropped 45.8 mg/dL (21.78%) vs 14.4 mg/dL (6.97%) for placebo; HDL-C rose 3.3 mg/dL (8.39%) vs a 2.4 mg/dL (6.23%) decline; HDL-P rose 3.62 µmol/L (11.80%) vs a 0.9 µmol/L (3.00%) decline.
At the time of this announcement, MNOV was trading at $2.41 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $127M. The 52-week trading range was $1.17 to $3.90. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.