A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects with Progressive Multiple Sclerosis
Multiple Sclerosis (MS) is a chronic, inflammatory demyelinating disease of the central nervous system that affects 400,000 people in the US and 2 million people worldwide. Those affected with the disease are characterized by their progression into one of three variants: relapsing-remitting, secondary-progressive and primary-progressive. Despite recent improvements in pharmacotherapy for relapsing-remitting Multiple Sclerosis (RRMS), there are no therapies with demonstrated efficacy in progressive Multiple Sclerosis in the absence of relapses.
NN102 is a study to determine the safety, tolerability and activity of ibudilast (MN-166) administered twice daily over a 96 week period in subjects with primary and secondary-progressive multiple sclerosis. A total of 255 subjects were randomly assigned to two treatment arms (ibudilast or matching-placebo), and the study utilized advanced brain imaging to assess activity and correlate clinical activity with these imaging measures.
Ibudilast demonstrated a statistically significant reduction in the rate of progression of whole brain atrophy compared to placebo, as measured by MRI analysis using brain parenchymal fraction. Additionally, ibudilast was found to be safe and well-tolerated. These results represent “an encouraging step forward in the development of treatments for progressive MS, which has historically been very difficult to treat,” according to Robert Fox, MD, NN102 SPRINT-MS PI.
NN102 was supported by NINDS (U01 NS082329) in partnership with Medicinova and the National Multiple Sclerosis Society.