MediciNova Inc（MNOV）のニュースとイベントMNOVMediciNova Inc

MediciNova Updates on MN-001 Clinical Trial Results

MediciNova provides shareholders an update on key findings from the recent topline results of its Phase 2 clinical trial evaluating MN-001 for the treatment of nonalcoholic fatty liver disease and hypertriglyceridemia associated with type 2 diabetes mellitus in the following letter from CEO Yuichi Iwaki, Ph.D. "To Fellow Shareholders, We continue to advance our key programs to create viable treatments for both metabolic disease and amyotrophic lateral sclerosis. Recently, we announced topline results of our Phase 2 clinical trial (MN-001-NATG-202) evaluating MN-001 (tipelukast) in patients with nonalcoholic fatty liver disease and hypertriglyceridemia associated with type 2 diabetes mellitus. This randomized, double-blind, placebo-controlled study enrolled 40 patients over a 24-week treatment period and was designed as an exploratory, proof-of-concept trial. We observed encouraging signals, although the trial did not achieve statistical significance on its primary endpoints. There were statistically significant improvements in high-density lipoprotein cholesterol and HDL particle concentration compared with placebo, as well as an early, statistically significant reduction in serum triglycerides. At the end of the 24-week treatment period, serum triglycerides, liver fat, and body weight were also reduced in the MN-001 group compared with placebo, although these differences did not reach statistical significance. These observations were consistent with findings from previous clinical trials and preclinical studies evaluating the mechanisms of action of MN-001 and with the directional signals anticipated from an exploratory study of this size. We are conducting further analyses of the full dataset to better understand the observed outcomes, including the potential influence of concomitant medications and baseline severity of lipid abnormalities. MN-001 was well tolerated in this study, with no drug-related serious adverse events reported, consistent with the favorable safety profile observed among more than 650 subjects exposed to MN-001 in prior clinical studies, including studies that evaluated substantially higher doses than the dose used in the current trial. We believe the observed changes are clinically relevant and that we have met our overarching goal of demonstrating proof of concept of MN-001 in this treatment context. The findings support continued evaluation of MN-001. Once our analyses are sufficiently advanced, we will use the results to assess potential next steps for this indication, including how the program may proceed, and will provide updates as appropriate. We are also approaching a significant milestone for our lead asset, MN-166 (ibudilast), for ALS. In September, we announced completion of the last patient, last visit in the double-blind portion of COMBAT-ALS, our Phase 2b/3 trial evaluating MN-166 in 234 patients with ALS. The trial's primary endpoint is the Combined Assessment of Function and Survival, and we remain on track to report topline results by year-end. MN-166 has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for ALS, as well as orphan designation in Europe. ALS remains a devastating disease with limited treatment options. We look forward to continued communication around our development of MN-001 in metabolic disease. We believe MN-001 remains a worthwhile pursuit and are encouraged by signals observed to date. We also look forward to sharing topline results from COMBAT-ALS and advancing MN-166 as a potential treatment for people living with ALS. We are grateful for our shareholders' ongoing support and remain committed to creating long-term value for our shareholders."

MediciNova MN-001 Clinical Trial Results Show Beneficial Effects

MediciNova announced the topline results from MN-001-NATG-202, a Phase 2 clinical trial evaluating MN-001 for the treatment of hypertriglyceridemia and nonalcoholic fatty liver disease associated with type 2 diabetes mellitus. In the MN-001 group, reductions in serum triglycerides, increases in serum high-density lipoprotein cholesterol and HDL particle concentration, and a numerical trend toward improvement in liver fat and body weight were observed. MN-001 demonstrated a generally favorable safety and tolerability profile. The study demonstrated a statistically significant reduction in serum TG at Week 4 with MN-001 than with placebo. At Week 24, the MN-001 group continued to show a numerical reduction from baseline value, although the difference between the MN-001 and placebo groups were not statistically significant. Statistically significant increases in HDL-C and HDL-P were also observed with MN-001 group while liver fat and body weight showed trends toward improvement. Collectively, these exploratory findings suggest that MN-001 may have beneficial effects across in several metabolic parameters including lipid metabolism, body weight, and liver fat. The changes in TG, HDL-C, and HDL-P were also consistent with findings from preclinical in-vitro mechanism of action studies and previous MN-001-NATG-201 clinical trial. Together with the clinical findings, these results provide a basis for further evaluation of MN-001 in metabolic and cardiovascular diseases.

MediciNova Completes Last Patient Visit in COMBAT-ALS Clinical Trial

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 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. Participants who remain active in the study are continuing treatment with MN-166 in the Open-Label Extension phase. The LPLV for the entire study is expected in March 2027. MediciNova expects to report topline results from the double-blind portion of the study by the end of 2026.