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news.Biopharmaceutical company MediciNova has reported positive results from a Phase IIa clinical study of its novel intravenous product candidate for the treatment of acute severe asthma attack.
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The randomized, double-blind, placebo controlled, dose-escalation study achieved statistical significance in its primary endpoint of mean change in FEV1 (forced expiratory volume in 1 second) from baseline at 15 minutes (the end of the infusion) at doses of 10, 16, 30 and 60 micrograms/min of novel intravenous asthma product, MN-221 compared to placebo. There were no clinically significant cardiovascular, electrocardiogram, or vital sign changes, nor were there any other safety concerns observed at any dose tested.
Yuichi Iwaki, president and CEO, said: “We are extremely pleased and encouraged by the Phase IIa clinical study results and believe that MN-221 has the potential to become a new standard of care for status asthmaticus.
“The improvements in FEV1 and favorable cardiac safety findings also suggest that MN-221 could be broadly useful in management of asthma and other obstructive lung diseases such as chronic obstructive pulmonary disease. We look forward to further progressing MN-221 through clinical development.”