MediciNova reports positive preliminary results from Phase II asthma study

This is one of two Phase II clinical trials being conducted to evaluate MN-221 in various populations of asthma patients. This clinical trial provided information on prolonged infusion dosing regimens with MN-221, and the preliminary results demonstrated clinically significant improvements in forced expiratory volume in one second (FEV1).

This randomized, open-label, placebo-controlled Phase II clinical trial involved 17 patients in two dose cohorts at four clinical sites in the US. In one dosing cohort, each patient received MN-221 at a dose of 1,125 micrograms or placebo over one hour by a continuous intravenous infusion. In the other dosing cohort, each patient received MN-221 at a dose of 1,080 micrograms or placebo over two hours by a continuous intravenous infusion.

Based on preliminary findings, both infusion rates of MN-221 produced a marked and clinically significant improvement in FEV1. FEV1 results were expressed as ‘percent predicted’ based on standard reference equations accounting for an individual’s race, gender, age and height.

At the end of the one-hour infusion, FEV1 increased by 17.5% predicted for MN-221 compared to an increase of 3% predicted for placebo. At the end of the two-hour infusion, FEV1 increased by an average of 12.1% predicted for MN-221 compared to an increase of 1.4% predicted for placebo. MN-221 was well tolerated by the patients who received either infusion rate of MN-221.

Yuichi Iwaki, president and CEO of MediciNova, said: “This clinical trial for MN-221, in parallel with our other Phase II clinical trial currently underway in patients with severe, acute exacerbations of asthma treated in the Emergency Department, will assist us in designing a larger Phase IIb clinical trial, which we hope to initiate during peak asthma attack season this winter.”