MediciNova reports mixed signals from MN-001 clinical trial
The Phase 2 study missed its primary endpoints, while several lipid measures improved; the company is reviewing the full dataset.
Key takeaways
- The 40-patient MN-001 trial did not meet its primary endpoints.
- HDL measures improved significantly versus placebo, while other end-of-trial changes were not statistically significant.
- MediciNova remains on track to report COMBAT-ALS topline results by year-end.
MediciNova said its 40-patient Phase 2 trial of MN-001 in people with fatty liver disease and high triglycerides associated with type 2 diabetes did not meet its primary endpoints. The company reported statistically significant improvements in HDL cholesterol and HDL particle concentration compared with placebo.
Triglycerides fell significantly at an early point in the trial, the company said. At the end of the 24-week study, triglycerides, liver fat and body weight were lower in the MN-001 group than in the placebo group, but those differences were not statistically significant.
CEO Yuichi Iwaki said the company is conducting further analysis, including examining the possible effects of other medications and patients’ baseline lipid severity. MediciNova reported no drug-related serious adverse events in the trial. Iwaki said the findings support further evaluation, with next steps to be considered after the analyses advance.
The company also said it remains on track to report topline results by year-end from COMBAT-ALS, its Phase 2b/3 trial of MN-166 in 234 patients. In September, MediciNova announced that the last patient had completed the last visit in the study’s double-blind portion.
This article was produced with the help of AI technology. Source: Yahoo Finance
