MAP Pharmaceuticals (MAPP) Phase 3 Study of Budesonide in Children With Asthma Doesn't Meet Primary Endpoints

February 23, 2009 5:11 PM EST

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced today results of its initial Phase 3 clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of children with asthma. The Company announced 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.

"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," said Timothy S. Nelson, Chief Executive Officer of MAP Pharmaceuticals. "We and our partner, AstraZeneca (NYSE: AZN), are conducting further analyses of these data to determine appropriate next steps going forward for the program. The Company remains dedicated to developing therapies for children suffering from asthma."[SM]

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