MEDICINOVA BEGINS TRIAL PROGRAM FOR ASTHMA TREATMENT

MediciNova has initiated a Phase III clinical program to determine the safety and efficacy of its novel oral treatment for bronchial asthma, MN-001.

The first Phase III trial in this program will involve approximately 705 asthma patients enrolled at 75 to 90 clinical sites in the U.S. Mild-to-moderate asthma patients will receive placebo or MN-001 for 12 weeks in this randomized, placebo-controlled, double-blind study. The primary endpoint of the trial will be the change from baseline in mean FEV1 (forced expiratory volume in one second) after 12 weeks of treatment. Secondary outcome measures will include a self-administered asthma quality-of-life questionnaire, the change from baseline in morning and evening peak flow rates, rescue beta-agonist use, serial spirometry parameters including assessment of acute effects following first dose on day one, daytime asthma symptom scores, nighttime awakenings from asthma, physician's global assessment, number of asthma exacerbations, discontinuations due to asthma, clinical global impression evaluations and change in urinary LTE4 levels. Additional Phase III trials are planned. Development of a continuous-release formulation of MN-001 will parallel the initial Phase III trials.

MN-001 is a novel, orally bioavailable compound that has been shown to block a number of the inflammatory mechanisms activated by mast-cell degranulation (e.g., leukotriene receptor antagonism and inhibition of phosphodiesterases III and IV, 5-lipoxygenase, phospholipase C and thromboxane A2) that are important in the pathogenesis of inflammatory disorders including asthma.

MN-001 is also under development by MediciNova for the treatment of interstitial cystitis. MN-001 is currently being evaluated in a pivotal-design Phase II/III clinical trial in 305 patients with moderate-to-severe interstitial cystitis at 39 clinical sites in the U.S. MediciNova anticipates having results from this trial by the beginning of 2007.