AstraZeneca and Targacept, Inc. today announced top-line results from the second of four RENAISSANCE Phase 3 studies investigating the efficacy and tolerability of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant treatment. The study, RENAISSANCE 2, did not meet its primary endpoint, change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score after eight weeks of adjunct treatment with TC-5214 as compared to placebo.
These results follow the recent announcement of top-line results from RENAISSANCE study 3, which also did not meet its primary endpoint. Both RENAISSANCE 2 and RENAISSANCE 3 were flexible dose trials. The two remaining efficacy studies in the RENAISSANCE Program for TC-5214 are fixed dose trials. Top-line results for both fixed dose trials, as well as for a long-term study designed primarily to evaluate safety, are expected to be available in the first half of 2012.
TC-5214 was overall well tolerated in RENAISSANCE study 2 and showed an adverse event profile generally consistent with prior clinical trials of TC-5214. Analyses of the full data set from the RENAISSANCE study 2 remain ongoing.
Regulatory filing targets will be reviewed following results of the remaining RENAISSANCE Program studies. A potential New Drug Application filing in the United States is planned for the second half of 2012, with a potential EU Marketing Authorization Application filing targeted for 2015.