Biopharmaceutical company MediciNova Inc. 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.
“We are very pleased with the positive safety data and early efficacy findings for MN-221,” said Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc. “These results add important value to our ongoing strategic development of our pivotal clinical program for MN-221 and we look forward to discussing this data at our upcoming End-of-Phase 2 meeting with the FDA’s respiratory division in late October.”
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.
“There is a significant unmet medical need for an IV agent like MN-221 for asthma and COPD patients who are admitted to the ER due to a severe episode that is unresponsive to standard therapy,” said Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer. “The results of this trial will help us optimize both the trial design and operational considerations for our pivotal program in acute asthma exacerbations.”
Date: August 23, 2012
Source: MediciNova Inc.
Filed Under: Drug Discovery