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AstraZeneca and Targacept, Inc. today announced top-line results from the remaining Phase 3 studies investigating efficacy, tolerability and safety of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder (MDD) who did not respond adequately to initial antidepressant treatment. RENAISSANCE 4 and RENAISSANCE 5, both efficacy and tolerability studies, did not meet the primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) total score after eight weeks of adjunct treatment with TC-5214 as compared to placebo.
In both RENAISSANCE 4 and RENAISSANCE 5, as well as in the previously completed RENAISSANCE 2 and RENAISSANCE 3 studies, every dose group (TC-5214 and placebo) showed at least a 40 percent improvement in MADRS total score after eight weeks of adjunct treatment. TC-5214 was overall well tolerated in RENAISSANCE 4 and RENAISSANCE 5 with an adverse event profile generally consistent with prior clinical trials.
In RENAISSANCE 7, a long-term study designed primarily to evaluate the safety of TC-5214, together with an antidepressant treatment, for one year, TC-5214 was overall well tolerated, with an adverse event profile generally consistent with prior clinical trials.
These studies conclude the RENAISSANCE Program for TC-5214. Based on the totality of the results, AstraZeneca and Targacept will not pursue a regulatory filing for TC-5214 as an adjunct treatment for patients with MDD.
“Since the readout from the first RENAISSANCE Program outcomes, we have been carefully scrutinizing all aspects of our business to prepare for this contingency, and we will announce our plans by the end of April,” said J. Donald deBethizy, Ph.D., Targacept’s President and Chief Executive Officer. “Targacept has built a deep and mechanistically diverse clinical pipeline, and, with multiple NNR Therapeutics in Phase 2 development in areas of large medical need and commercial opportunity and over $225 million in cash, we are well positioned for future success.”