For The Treatment of Interstitial Cystitis
MN-001 is a novel, orally bioavailable compound under development for the treatment of IC. In preclinical testing MN-001 was shown to block a number of the inflammatory mechanisms activated by mast cell degranulation that are important in the pathogenesis of inflammatory disorders including IC and asthma (e.g., leukotriene receptor antagonism and inhibition of phosphodiesterases III and IV, 5-lipoxygenase, phospholipase C and thromboxane A2). MN-001 produced anti-inflammatory effects in a variety of rodent models of IC and asthma; in these models, MN-001 reduced bladder hyper-reactivity much in the same way that it reduces airway hyper-reactivity in the lung.
MediciNova completed a randomized, double-blind, placebo controlled Phase II/III clinical study of MN-001 for the treatment of IC. A total of 305 patients were enrolled in this study. Although MN-001 was well-tolerated in this study, it did not show a statistically significant clinical benefit compared to placebo on the primary endpoint (to be much or very much improved overall on a patient-rated Global Response Assessment) at the doses tested in this trial (500 mg once or twice a day for 8 weeks).
Results from this Phase II/III trial indicated that IC patients were more than twice as likely to respond on 500 mg of MN-001 administered twice a day compared to placebo (25% compared to 12%, p=0.04) after 4 weeks of treatment. This difference, however, was not observed at 8 weeks due to continued improvement among placebo-treated patients. The response rate of patients treated with 500 mg of MN-001 once a day did not significantly differ from placebo at either 4 or 8 weeks.
We will limit our development efforts on MN-001 for the treatment of IC to those activities necessary to maximize MN-001’s value while pursuing a variety of initiatives to monetize this product candidate.