Phase Ib Study – MN-221-CL-012
In August 2012, we announced positive preliminary results of a Phase 1b clinical trial involving multiple administrations of intravenous (IV) MN-221 (bedoradrine) over several days in patients with stable, moderate-to-severe chronic obstructive pulmonary disease (COPD). The majority of the subjects completed the study and there were no clinically significant safety concerns. In addition, preliminary pharmacokinetic and efficacy findings were encouraging. A total of 25 subjects were randomized to placebo (5 subjects) or MN-221 (20 subjects) treatment groups; with similar enrollment at each of two clinical research units. The patient group included those who had concomitant illnesses and were using other medications that are typical in this disease population. Preliminary efficacy results indicated moderately improved pulmonary function (FEV1) in the MN-221 recipients but not the placebo recipients. Moreover, the improvement of FEV1 on subsequent MN-221 dosing days was as good as or better than on Day One. Regarding other strategic objectives, comparison of the simple hand-held FEV1 monitor with the spirometer machine used in our other clinical trials of MN-221 indicated good correlation and pharmacokinetic analyses indicated no significant accumulation of plasma MN-221 over the multiple dosing intervals.