Map Pharmaceuticals’s Phase III asthma trial fails to meet primary endpoints

The company said that the clinical trial did not meet its co-primary endpoints, asthma control as assessed by changes from baseline in nighttime and daytime composite symptom scores, in either of the doses evaluated, when compared with placebo.

Median nebulization times were less than four minutes for both doses in the study. Initial review of the data has not identified any serious adverse events attributed to study drug. Patients continue to be treated in a 52-week safety study to collect long-term safety data on the two doses under investigation.

In the randomized, double-blind, placebo-controlled study, 360 steroid naive children with asthma, 12-months to eight years of age, were randomized to receive 0.25mg unit dose budesonide (UDB), 0.135mg UDB or placebo twice a day over a 12-week period. The co-primary endpoints evaluated asthma control as assessed by changes from baseline as compared to placebo in nighttime composite symptom scores, and daytime composite symptom scores, both comprised of cough, wheeze and shortness of breath.

Map Pharmaceuticals and AstraZeneca have a collaboration agreement to develop and commercialize UDB in the US, and AstraZeneca has rights to develop and commercialize UDB outside of the US.

Timothy Nelson, CEO of Map Pharmaceuticals, said: Based on our initial review of these data, both the placebo and study groups experienced improvements in asthma symptoms, but the differences were not statistically significant. We observed a higher than expected response in the placebo group, starting as early as one week after randomization and continuing throughout the 12-week treatment period. We and our partner, AstraZeneca, are conducting further analyses of these data to determine appropriate next steps going forward for the program.