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news.MediciNova has begun enrollment of patients for a phase II clinical study of MN-166, an orally administered drug for the treatment of multiple sclerosis.
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Under a licensing agreement with Kyorin Pharmaceutical of Tokyo, MediciNova obtained exclusive worldwide rights, in all territories 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, for the treatment of asthma and cerebro-vascular disorders.
“MN-166 may represent a significant advance in the treatment of relapsing-remitting MS,” stated Dr Richard Gammans, 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).