MediciNova starts phase II clinical trial of MN-166 for multiple sclerosis

MediciNova today announced the enrollment of patients in a Phase II clinical study with MN-166 for the treatment of multiple sclerosis (MS), an inflammatory demyelinating disease of the central nervous system. MN-166 is an orally administered drug with a novel mechanism of action that includes the inhibition of phosphodiesterase IV.

Under a licensing agreement with Kyorin Pharmaceutical Co. Ltd. of Tokyo, Japan, MediciNova obtained exclusive worldwide rights, except for Japan, China, Taiwan and South Korea, to develop and commercialize MN-166 for multiple sclerosis. For the past 16 years, MN-166 has been marketed in Japan as Ketas(R) (ibudilast), for the treatment of asthma and cerebrovascular disorders. Ibudilast was also launched in Korea in September 2002.

"MN-166 may represent a significant advance in the treatment of relapsing-remitting MS," stated Richard Gammans, Ph.D., Chief Development Officer at MediciNova. "It has a proven record of safety and tolerability, and has the major advantage of oral dosing. In small, open label studies in patients with relapsing-remitting MS, MN-166 produced some rather encouraging activity. This Phase II study is being conducted in nine countries in Eastern Europe and will compare two oral doses of MN-166 to placebo in 300 patients with relapsing-remitting MS."

The study will measure reduction in MS lesions in the brain as detected by MRI (magnetic resonance imaging), reductions in annualized relapse rates and functional status as determined by the EDSS (Expanded Disability Status Scale).