MediciNova Drug Falls Short on Liver Fat Parameter, Stock Tumbles

MediciNova Inc. (NASDAQ:MNOV) stock is trading lower on Monday after the company reported mixed topline results from its Phase 2 clinical trial evaluating MN-001 (tipelukast) for hypertriglyceridemia and nonalcoholic fatty liver disease (NAFLD) associated with type 2 diabetes mellitus. The exploratory study highlighted improvements in cardiovascular lipid markers, alongside positive trends in liver fat reduction and body weight loss. Phase 2 Trial Design And Efficacy Findings The MN-001-NATG-202 study evaluated the efficacy, safety, and tolerability of MN-001 over a 24-week treatment period in 40 patients. At Week 4, participants receiving MN-001 experienced a statistically significant mean decrease in serum triglycerides of 54.7 mg/dL (26.05%), compared to a 23.8 mg/dL (11.54%) reduction in the placebo arm (p=0.015). Read Also: Move Over Novo Nordisk – This Small Company Study Flags Edge In Fatty Liver Drug By Week 24, serum triglycerides in the MN-001 cohort dropped by 45.8 mg/dL (21.78%) versus 14.4 mg/dL (6.97%) for placebo, representing a numerical improvement of 31.4 mg/dL. At Week 24, MN-001 generated a statistically significant increase in mean HDL cholesterol of 3.3 mg/dL (8.39%), whereas placebo levels fell by 2.4 mg/dL (6.23%) (p=0.0048). HDL particle concentration also rose significantly by 3.62 µmol/L (11.80%) in the MN-001 group, compared to a 0.9 µmol/L (3.00%) decrease in placebo (p=0.018). Regarding liver fat, controlled attenuation parameter scores measured by FibroScan dropped by 14.1 dB/m (4.24%) with MN-001 versus 4.3 dB/m (1.27%) with placebo. However, the difference was not statistically significant (p=0.2438). Additionally, the treatment group lost a mean of 4.91 pounds (2.28%) compared to 0.55 pounds (0.25%) in the placebo arm. Safety Profile And Next Steps MN-001 showed a favorable safety and tolerability profile throughout the study. Treatment-related adverse events remained mild to moderate, with zero drug-related serious adverse events reported. These clinical findings align with earlier preclinical in vitro mechanism of action studies and results from the prior MN-001-NATG-201 trial. Following this 40-patient proof-of-concept study, MediciNova plans to complete detailed data analyses to assess the next stage of clinical development. MNOV Price Action: MediciNova shares were down 26.36% at $2.36 at the time of publication on Monday, according to Benzinga Pro data. Read Also: Bill Gates Tells Trump Not to Slow AI Innovation, Slams ‘Kill Switch’ Debate — Warns ‘A Billion Deaths’ Could Be Possible Without Safeguards Image via Shutterstock/ Naeblys