The European and American Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) selected the presentation “SPRINT-MS/NN 102 phase II trial of ibudilast in progressive MS: top-line results” to be included in the late-breaking news session on the last day of the meeting, held Oct. 25–28, the company reported in a press release.
Dr. Robert Fox, a neurologist at the Cleveland Clinic and the trial’s principal investigator, will present the study data.
The SPRINT-MS Phase 2b trial (NCT01982942), which ended in May, explored ibudilast in both primary and secondary progressive MS patients over 96 weeks of treatment.
The 255 study participants were randomly assigned either ibudilast or placebo. But the randomization process took into account if patients were new to treatment, or if they were continuing to take other medications. Patients were allowed to continue using Copaxone (glatiramer acetate) or drugs containing interferon (IFN beta-1a or IFN beta-1b).
Those who received the active drug took 50 mg tablets twice a day, for a total daily dose of 100 mg.
The trial aims to assess the activity of ibudilast on whole brain atrophy, as well as its safety and tolerability in patients with primary progressive or secondary progressive MS.
Although the company did not give an indication of treatment outcomes, a December 2016 review by a Data and Safety Monitoring Board recommended the trial continue after observing enough promising data.
At that point, about half of enrolled patients had completed the study, which is performed within the scope of the NeuroNEXT network in collaboration with the National Institutes of Health (NIH), the National Institute of Neurological Disorders and Stroke (NINDS), and the National Multiple Sclerosis Society.
Ibudilast has long been used in Japan and Korea to treat post-stroke complications and bronchial asthma — two seemingly very different conditions that, nevertheless, say something about the drug’s promise in MS. The treatment acts to block two enzymes known as phosphodiesterases (PDE) -4 and -10, and inhibits macrophage migration inhibitory factor (MIF). These actions lead to a suppression of inflammatory responses and a boost in the activity of neural growth factors.
Studies have also shown that ibudilast prevents brain immune cells, called glia, from becoming activated, likely contributing to its neuroprotective effects.
MediciNova is also developing ibudilast to potentially treat amyotrophic lateral sclerosis (ALS) and drug addiction.