Bedoradrine: Preliminary Phase IIb data

Preliminary data from 144 evaluable patients with acute exacerbations of asthma in the double-blind, U.S. Phase IIb MN-221-CL-007 trial showed that a 1-hour IV infusion with 1,200 µg MN-221 as an adjunct to standard of care (SOC) missed the primary endpoint of improving percent predicted FEV1 from baseline at 3 hours vs. placebo plus SOC. On secondary endpoints, MN-221 improved FEV1 area under the curve (AUC) from 0-1 hour (0.065 vs. 0.02 L, p=0.043), 0-2 hours (0.231 L vs. 0.085, p=0.05) and 0-3 hours vs. placebo (0.435 vs. 0.24 L, p=0.066). Additionally, MN-221 improved dyspnea score AUC from 0-2 hours by 38% over placebo (p=0.062) and from 0-3 hours by 34% over placebo (p=0.055). Furthermore, a non-significantly smaller proportion of patients receiving MN-221 were hospitalized compared to placebo (38% vs. 46%). Other than asthma-related events, there were 2 serious adverse events including 1 case of bronchitis each with MN-221 and placebo and 1 case of pneumonia with MN-221. ...