MediciNova completes enrollment for phase II asthma trial

MN-001, which is orally administered, is a leukotriene receptor antagonist and an inhibitor of phosphodiesterases III and IV, 5-lipoxygenase, and thromboxane A2. MediciNova licensed it from Kyorin Pharmaceutical with exclusive worldwide rights, except for Japan, China, Taiwan and South Korea.

The current clinical study of the drug, which has been ongoing for six months, has enrolled 147 patients with mild to moderate asthma.

The placebo-controlled study is designed to evaluate trends in the effectiveness of three different dosing regimens of MN-001 on improvement of respiratory function by various measures, including increases in forced expiratory volume, reduction in the response to methacoline challenge, and the duration of these improvements following dosing and improvement after four weeks of treatment compared with that observed on the first day of treatment. The safety and tolerability of MN-001 will also be evaluated.

“We are very encouraged by how quickly and efficiently this study has been conducted,” stated Dr Richard Gammans, chief development officer at MediciNova, “The trial should be completed two months ahead of schedule. It is worth noting that we have seen very few patients drop out of the study, and we are hopeful that once the data are available we will have confirmation of safety and tolerability together with evidence of efficacy that will signal the continued development of MN-001.”