Potential new medication for progressive MS shows promise in early trial

While the treatment armamentarium for MS has vastly expanded in the last decade and continues to grow, these treatments have been predominantly for the relapsing forms of the disease, and effective treatments for progressive MS remain a glaring need.

Ibudilast (MN-166, MediciNova) is a phosphodiesterase inhibitor with anti-inflammatory properties and potentially neuroprotective activity as well, which was tested in a Phase 2 trial of progressive MS patients.

Ibudilast has been marketed in Japan and Korea to treat some post-stroke complications and asthma. It is not currently available in the United States.

In a previous Phase 2 trial of Ibudilast in relapsing patients, the drug seemed to have a greater benefit for brain atrophy and disability than inflammatory MRI activity. This finding, along with results from in vivo and in vitro research provided the rationale for testing this medication in progressive MS.

The “Sprint-MS/NN 102 Phase II Trial of Ibudilast in Progressive MS” was conducted at 28 centers in the U.S. that are a part of the NeuroNEXT Network, which is a consortium of MS centers formed as an initiative of the National Institutes of Health to facilitate research. Additional support for the study was provided by MediciNova and the National MS Society. The Weill Cornell Medicine MS Center was one of the sites that participated in the study. Jai Perumal was the principal investigator for the Cornell site.

255 patients with primary or secondary progressive MS were enrolled into the study. The duration of the study was 96 weeks. Patients were randomized to Ibudilast or placebo medication. The primary endpoint was the rate of change of brain atrophy. Safety evaluations were other endpoints.

Results from the study showed that the rate of brain atrophy was reduced by 48 percent in patients taking Ibudilast when compared to placebo medication.

There was no significant difference in the risk of serious adverse events between patients taking Ibudilast and placebo medication. Side effects which were more common in the Ibudilast group when compared to placebo medication included, rash, fatigue, nausea, vomiting, diarrhea and depression.

The results were presented at international MS meetings and further details are expected to be published in a journal soon.

The results of this trial are very promising for the treatment of progressive MS. Next steps in the development of Ibudilast for progressive MS, including Phase 3 trials, are being considered.

by

Jai Perumal