MediciNova announces 'positive' FDA feedback on Phase 3 plan for MN-166
MediciNova announced it has received positive feedback from the FDA regarding MediciNova's Phase 3 clinical development plan for MN-166 in amyotrophic lateral sclerosis. Key points from the FDA's feedback include the following: If a single trial shows that MN-166 has a statistically significant benefit compared to placebo in a measure of functional activity, such as ALSFRS-R, an additional trial may not be necessary; In order to detect the maximal potential benefit of MN-166, FDA encouraged including a broad ALS population, with randomization that is stratified by baseline disease severity; no safety issues regarding MN-166 were raised by the FDA and the safety profile will be revisited once the pivotal results are available; given that the indication is for ALS, a rare disease, there may be flexibility in the requirements to support a marketing application. Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are excited to receive the green light from FDA to proceed with Phase 3 development of MN-166 for ALS. We will finalize the study design according to FDA's feedback."