MediciNova Trials Make Significant Progress with Enrollment Update

MediciNova provides an update on the enrollment of two key ongoing clinical trials for MN-166 (ibudilast) and MN-001 (tipelukast). The company is nearing completion of patient randomization in its Phase 2/3 COMBAT-ALS trial and seeking the final two randomized subjects for its Phase 2 trial in patients with dyslipidemia and fatty liver disease due to type 2 diabetes. Top-line data is expected by the end of next year.

MediciNova, Inc. has provided an update on the enrollment of two key ongoing clinical trials for its developmental compounds MN-166 (ibudilast) and MN-001 (tipelukast). The company is nearing completion of patient randomization in its Phase 2/3 COMBAT-ALS trial and seeking the final two randomized subjects for its Phase 2 trial in patients with dyslipidemia and fatty liver disease due to type 2 diabetes. Top-line data is expected by the end of next year.

The Phase 2/3 COMBAT-ALS trial, which is evaluating ibudilast for the treatment of amyotrophic lateral sclerosis (ALS), is now down to single-digit patient enrollment requirements [1]. This significant milestone follows the release of interim results last year and runs parallel to the company's large Expanded Access Program (EAP), which is actively enrolling patients and supported by a $22 million grant from the NIH. The company is preparing for regulatory discussions with the FDA and anticipates top-line data by the end of 2026.

Concurrently, the Phase 2 trial studying tipelukast for dyslipidemia and fatty liver disease in type 2 diabetes patients requires just two more participants to complete randomization [2]. This trial aims to evaluate the compound's potential to treat fibrotic and metabolic disorders, including nonalcoholic fatty liver disease (NAFLD) and hypertriglyceridemia.

MediciNova's progress in these clinical trials underscores the company's commitment to addressing highly unmet medical needs in difficult-to-treat conditions. The company's strategy to focus on neurological and metabolic disorders aligns with its goal of advancing its pipeline through various clinical development approaches, including investigator-sponsored trials, government-funded grants, and strategic alliances.

References:
[1] https://finance.yahoo.com/news/medicinova-provides-enrollment-ongoing-als-100000709.html
[2] https://www.stocktitan.net/news/MNOV/medici-nova-provides-enrollment-update-for-ongoing-als-and-ruj8mamhsqwz.html