AZD1446: Phase IIa data
Top-line data from a double-blind, crossover, U.S. Phase IIa trial in 79 patients ages 18-65, including 27 nicotine and 52 non-nicotine users, showed that AZD1446 missed the primary endpoint of significantly improving core symptoms of ADHD after 2 weeks of treatment as measured by CAARS-INV scores vs. placebo. Nicotine users received once-daily 80 mg AZD1446, thrice-daily 80 mg AZD1446 and placebo each for 2 weeks in random order. Non-nicotine users received 2 of 3 AZD1446 regimens - once- or thrice-daily 80 mg AZD1446 or 10 mg thrice-daily AZD1446 - and placebo each for 2 weeks in random order. Dosing periods were separated by a 3-week washout period, for a total study duration of 12 weeks. All endpoints were evaluated at the end of each 2-week dosing period.
Based on the results, Targacept said that it does not expect partner AstraZeneca to continue development of AZD1446 as a treatment for ADHD. The pharma is expected to make a decision regarding the future development of the compound to treat Alzheimer's disease, for which it is in Phase II testing, in the coming months. ...