MEDICINOVA ANNOUNCES FINDINGS FROM IC STUDY

MediciNova announced the results from its Phase II/III randomized, double-blind, placebo-controlled clinical trial of MN-001 in 305 patients with moderate-to-severe interstitial cystitis (IC), a chronic disease of the bladder. While MN-001 was well tolerated, it did not show a statistically significant clinical benefit compared with placebo on the primary endpoint at the doses tested in this trial (500 mg once or twice a day for eight weeks).

Results from the trial indicated that IC patients were more than twice as likely to respond on 500 mg of MN-001 administered twice a day than to placebo (25 percent compared with 12 percent) after four weeks of treatment. This difference, however, was not observed at eight 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 four or eight weeks.

"Although we are disappointed that MN-001 did not demonstrate a statistically significant improvement in IC symptoms, we believe that the compound warrants continued development, especially in bronchial asthma where positive clinical trial results have been observed at higher doses," Yuichi Iwaki, chairman and CEO of MediciNova, said.

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 that are important in the pathogenesis of inflammatory disorders including IC and asthma, according to the company. MN-001 produces anti-inflammatory effects in a variety of rodent models of IC and asthma; in these models, MN-001 reduces bladder hyper-reactivity much in the same way that it reduces airway hyper-reactivity in the lung.