MEDICINOVA INITIATES TRIAL OF INSOMNIA TREATMENT

MediciNova has begun a Phase II clinical study to determine the safety and efficacy of MN-305 for the treatment of insomnia. MN-305 is a potent and highly selective full agonist at the serotonin 5-HT1A receptor under development for the treatment of insomnia as well as for anxiety disorders. MN-305 has been evaluated in an extensive preclinical toxicology program, which showed no evidence of mutagenicity, antigenicity or carcinogenicity. MN-305 has also proved to be consistently well tolerated in clinical safety, efficacy and pharmacokinetic studies in more than 1,200 subjects.

MediciNova intends to explore the potential of MN-305 as a treatment for insomnia based on clinical observations of a beneficial therapeutic effect on insomnia in patients with generalized anxiety disorder (GAD). In a recently completed Phase II/III randomized, double-blind, placebo-controlled clinical trial of MN-305 in 416 patients with GAD, a statistically significant improvement in the insomnia item of the Hamilton Anxiety Rating Scale (HAM-A) was observed in patients treated with 0.5 to 6 mg of MN-305 per day.

To further test this clinical finding, MediciNova will conduct a Phase II, randomized, double-blind, placebo-controlled, crossover, dose-response study to assess the safety and efficacy of MN-305 in patients with primary insomnia with sleep maintenance difficulties. This study will assess the effects of three dosages of MN-305 (1, 3 and 6 mg) and placebo, all administered orally approximately 60 minutes before bedtime in 75 subjects.

MediciNova acquired a license to MN-305 from Mitsubishi Pharma for global markets, with the exception of Japan and certain other Asian countries.