While multiple sclerosis (MS) is considered a rare condition with major unmet medical needs, the treatments for progressive forms of MS are even scarcer, with no viable, FDA-approved drugs available to specifically address these forms of the disease. Because of this, the MS community is eagerly following a major study led by the Cleveland Clinic Foundation to evaluate MN-166 (ibudilast), a novel treatment developed by MediciNova, Inc. specifically to treat progressive MS. The investigators recently announced the completion of patient enrollment for the phase II clinical trial.
The phase II study will take place at 28 clinical sites in the United States and is designed to evaluate the oral-inflammatory compound MN-166 in 250 patients who suffer from primary or secondary progressive MS. The trial’s principal investigator is Robert Fox, MD, MS, FAAN, a neurologist from the Mellen Center for Multiple Sclerosis at the Cleveland Clinic.
Ibudilast works by inhibiting the phosphodiesterase enzyme, causing inflammation suppression. The agent has already been studied in a phase II trial involving 292 patients with relapsing MS and was found to decrease relapses. The study also revealed evidence that it could protect the nervous system from damage caused by the disease. The product is already approved in both Japan and Korea for the treatment of cerebrovascular conditions and asthma, while it is also being studied in the U.S. for drug addiction.
The study is being supported by MediciNova, as well as by an initiative from the National Institutes of Health (NIH), called the NeuroNEXT Network. In addition, the National MS Society has joined the project not only with financial support, but also by advocating among the MS community to increase clinical trial participation.
The organization believes that through this study, researchers may be able to both increase knowledge of the disease, as well as improve and accelerate treatment for patients with MS. “There is a significant, unmet need for treatments that can benefit people with progressive forms of MS,” stated the chief research officer of the National MS Society, Timothy Coetzee, PhD in a press release.
“This clinical trial of ibudilast will provide important information on a potential way to stop MS damage, as well as how to measure treatment benefits, and aligns well with the Society’s research agenda for stopping MS progression,” added Coetzee. The trial is expected to last three years, including patient enrollment, treatment and data analyses. Data collection is scheduled to be completed by the end of next year.