Phase II Study – MN-221-CL-007
MN-221-CL-007 was a randomized, double-blind, placebo-controlled Phase 2 clinical trial which enrolled 175 patients in the United States. The trial enrolled patients who presented to the emergency department with an acute exacerbation of asthma and did not initially respond to complete standard-of-care pharmacotherapy including inhaled albuterol, inhaled ipratropium, and steroids. In order to be eligible for enrollment, patients needed to have baseline FEV1 (% predicted), after initial standard therapy, of <50% and therefore considered “severe” exacerbation subjects. Enrolled patients were randomized 1:1 to placebo vs. 1200 micrograms MN-221 i.v. infused over 1 hour.
MN-221 showed a significant benefit over placebo for FEV1 (liters) Area Under the Curve (AUC Hour 0-1, 0-2, 0-3) of change from baseline (p=0.043, p=0.050, p=0.066 respectively) in the data set defined below. The trial also demonstrated a reduction in hospital admissions with MN-221 added to standard drug treatments. Moreover, there was a significant improvement in clinical symptoms with MN-221-treated patients and the safety profile of MN-221 continues to be positive as no safety/tolerability issues of clinical significance were observed.
The data set presented below includes more than 85% of the 164 efficacy evaluable patients in the trial. This includes patients from all of the sites that enrolled a minimally sufficient number of patients (greater than three) and for whom all efficacy data were available including FEV1, dyspnea, respiratory rate, and hospitalization.
Highlights of MN-221-CL-007 Trial:
- Overall FEV1 improvement was better in the MN-221 treatment group than the placebo and standard-of-care (SOC) alone group.
- MN-221 showed a significant benefit over SOC alone for FEV1(L) Area Under the Curve (AUC Hr 0-1, 0-2, 0-3) of change from baseline, (p=0.043, p=0.050, p=0.066 respectively)
- MN-221 showed a significant improvement in clinical respiratory parameters including dyspnea score (shortness of breath).
- MN-221 improved AUC (Hr 0-3) of change in dyspnea score by 34% more than SOC alone (p=0.055)
- Fewer patients were hospitalized in the MN-221 treatment group than standard-of-care (SOC) alone group.
- MN-221 reduced the overall hospitalization rate by 17% vs. SOC alone
- There were no significant clinical safety concerns when adding MN-221 to standard treatments.