MediciNova Inc

MediciNova, Inc. announced topline results from MN-001-NATG-202, a Phase 2 clinical trial evaluating MN-001 (tipelukast) for the treatment of hypertriglyceridemia and nonalcoholic fatty liver disease (NAFLD) associated with type 2 diabetes mellitus (T2DM). The randomized, double-blind, placebo-controlled study enrolled 40 patients over a 24-week treatment period. At Week 4, mean serum triglycerides decreased from baseline by 54.7 mg/dL (26.05%) in the MN-001 group versus 23.8 mg/dL (11.54%) in the placebo group, a statistically significant difference of 30.96 mg/dL with p=0.015; at Week 24, the mean decrease was 31.4 mg/dL greater with MN-001 than with placebo but was not statistically significant at p=0.113. At Week 24, mean HDL-C increased by 3.3 mg/dL (8.39%) in the MN-001 group versus a decrease of 2.4 mg/dL (6.23%) in the placebo group, a statistically significant difference of 5.7 mg/dL with p=0.0048, while mean HDL-P increased by 3.62 µmol/L (11.80%) in the MN-001 group versus a decrease of 0.9 µmol/L (3.00%) in the placebo group, a statistically significant difference of 4.52 µmol/L with p=0.018. Liver fat, measured by FibroScan controlled attenuation parameter, decreased by 14.1 dB/m (4.24%) in the MN-001 group versus 4.3 dB/m (1.27%) in the placebo group, a non-significant difference of 9.7 dB/m at p=0.2438, and body weight decreased by 4.91 lb (2.28%) in the MN-001 group versus 0.55 lb (0.25%) in the placebo group, a difference of 4.36 lb at p=0.082. MN-001 was generally safe and well tolerated, with treatment-related adverse events mild to moderate in severity and no drug-related serious adverse events reported. MediciNova said the exploratory 40-patient proof-of-concept study indicates efficacy should be evaluated in a larger study, and it will continue detailed analyses and assess the next stage of clinical development, including appropriate patient population, endpoints, and sample size.

MediciNova announced the completion of the last patient, last visit in the double-blind portion of COMBAT-ALS, a Phase 2b/3 clinical trial evaluating MN-166 (ibudilast) for the treatment of Amyotrophic Lateral Sclerosis. A total of 234 participants were randomized to two treatment arms at clinical sites in the United States and Canada, and participants who remain active in the study are continuing treatment with MN-166 in the Open-Label Extension phase. The company expects to report topline results from the double-blind portion of the study by the end of 2026, while the last patient, last visit for the entire study is expected in March 2027. The trial's primary endpoint is the Combined Assessment of Function and Survival, with secondary endpoints including change in the ALS Functional Rating Scale-Revised, muscle strength measured by hand-held dynamometry, and quality-of-life assessments. MN-166 has received Fast Track designation and Orphan Drug designation from the U.S. Food and Drug Administration, as well as orphan designation from the European Medicines Agency.

MediciNova announced that the target enrollment of 200 patients has been achieved in the SEANOBI-ALS study, an expanded access program evaluating MN-166 (ibudilast) in patients with amyotrophic lateral sclerosis. The study is funded by the National Institute of Neurological Disorders and Stroke under the ACT for ALS initiative and provides the investigational drug to individuals with ALS who are not eligible for ongoing randomized clinical trials. Final patient follow-ups are projected to conclude in early 2027, after which data analysis will begin to support scientific presentations and peer-reviewed publications. MN-166 is an orally available small-molecule inhibitor of phosphodiesterase-4 and inflammatory cytokines, and MediciNova previously completed enrollment in its COMBAT-ALS Phase 2b/3 clinical trial of the same compound in September 2025.

MediciNova has completed the last patient last visit in its Phase 2 clinical trial of MN-001 (tipelukast) for hypertriglyceridemia and nonalcoholic fatty liver disease associated with type 2 diabetes, with top-line data expected in the third quarter of 2026. The company also enrolled 100 patients, half of the planned 200, in the SEANOBI expanded-access program evaluating MN-166 (ibudilast) in amyotrophic lateral sclerosis. A U.S. patent notice of allowance was received for ibudilast combined with an anti-PD-1 antibody for glioblastoma, expiring no earlier than September 2042. Additionally, a peer-reviewed study showed ibudilast can block brain metastasis growth by inhibiting MIF-CD74 signaling. MediciNova now has four equity research firms covering the stock, up from one eighteen months ago, and expects topline data from its COMBAT ALS Phase 2b/3 registration trial by the end of 2026.