Pharmaceuticals’ stock took a beating after its late-stage asthma
therapy failed to meet its co-primary endpoints. Unit dose budesonide (UDB), which was being investigated in children, did not significantly improve asthma control in either of the doses evaluated when compared to placebo.
Patients continue to be treated in a 52-week safety study to collect long-term safety data on these two doses. AstraZeneca, MAP Pharmaceuticals’ partner for this drug, says that the firms will further analyze the data to determine how to proceed with the program.
The company’s stock dropped from $11.03 at the close of yesterday to open trading today at $3.79. This 65% drop could spell trouble for the company, which has another asthma/COPD treatment in Phase II development, a migraine drug in Phase III, and an antidiabetic in Phase I.
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. In this randomized, double-blind, placebo-controlled study, 360 steroid-naïve children with asthma, 12-months to eight years of age, were randomized to receive 0.25 mg UDB, 0.135 mg UDB, or placebo twice a day over a 12-week period. Median nebulization times were less than four minutes for both doses in the study.
“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,” explains Timothy S. Nelson, CEO of MAP Pharmaceuticals. “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.”
MAP Pharmaceuticals and AstraZeneca have a collaboration agreement to develop and commercialize UDB in the U.S. AstraZeneca has rights to the drug UDB outside the U.S.
To comment on this story, go to BLOGbiotech.