MediciNova (MNOV) provides an update on the enrollment of two key ongoing clinical trials for the company’s developmental compounds MN-166 (ibudilast) and MN-001 (tipelukast), each of which is poised to complete randomization. Specifically, the company is now down to single digit required randomization in its ongoing Phase 2/3 COMBAT-ALS trial. Concurrently, the company is seeking the final two randomized subjects for its Phase 2 trial in patients with dyslipidemia and fatty liver disease due to type 2 diabetes. Dr. Yuichi Iwaki, MediciNova President and CEO, commented, “We are pleased to report continued strong progress in our core COMBAT-ALS program. Following the release of interim results last year, we are now approaching the completion of patient randomization-a key milestone in the study. Our MN-166 ALS program continues to generate significant interest and anticipation within the ALS community. In parallel, the large Expanded Access Program, supported by a $22 million grant from the NIH, is steadily enrolling patients. We are actively preparing for regulatory discussions with the FDA, with top-line data anticipated by the end of next year. Further, we believe additional opportunities exist for our MN-001 compound in dyslipidemia and fatty liver disease patients due to type-2 diabetes. We believe each of these programs address highly unmet medical needs in very difficult-to-treat conditions, and we look forward to providing additional outcomes from each of these trials as results become available.”
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