MediciNova (NASDAQ:MNOV) received FDA approval to conduct a Phase 2b/3 clinical trial of MN-166 in amyotrophic lateral sclerosis (ALS) patients.
MN-166, or ibudilast, suppresses pro-inflammatory cytokines, promotes neurotrophic factors and reduces glial cell activity, which plays a major role in certain neurological conditions.
The Phase 2b/3 trial will enroll some 150 ALS patients in the U.S. Its primary endpoint will be the mean change in functional activity at nine months, and secondary endpoints will include mean change from baseline of muscle strength and quality of life.
“We are very pleased to have successfully completed the FDA review period and look forward to initiating patient enrollment shortly. The efficacy and safety data from this trial will potentially support an NDA and may lead to FDA approval of MN-166 for ALS,” Dr. Yuichi Iwaki, MediciNova’s president and CEO, said in a statement.
