Targacept's lead program for major depressive disorder fails to meet primary endpoint Print E-mail
By Staff and Wire Reports   
Tuesday, 08 November 2011 07:15
Top-line results from the first 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 failed to meet the primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) after eight weeks of treatment with TC-5214 as compared to placebo.

Wall Street Journal: AstraZeneca Dealt Setback on Antidepressant

AstraZeneca and Targacept (Nasdaq:TRGT) said that while analyses of the full data set from the RENAISSANCE 3 study remain ongoing. TC-5214 was overall well tolerated in the study and showed an adverse event profile generally consistent with the earlier Phase 2b study. The results announced today are from the RENAISSANCE 3 study, a flexible dose trial conducted in Europe. All RENAISSANCE Phase 3 studies have now completed enrollment, and reporting of all results is expected by the first half of 2012.

TC-5214 has the potential to be a first-in-class nicotinic channel modulator to serve as an adjunct treatment for MDD in patients with an inadequate response to initial antidepressant therapies, for example, selective serotonin reuptake inhibitors (SSRIs) or serotonin/norephinephrine reuptake inhibitors (SNRIs). This is Targacept's lead program and it is being co-developed with AstraZeneca.

The firms said an NDA filing in the US is planned for the second half of 2012, with an MAA filing in the EU targeted for 2015.

AstraZeneca, is seeking a new product to offset lost sales when patent protections on its Seroquel antipsychotic and Crestor cholesterol drugs expire, bought rights to TC-5214 from Winston-Salem, North Carolina-based Targacept in December 2009.

Targacept is scheduled to host a conference call today at 10 a.m. New York time to discuss the results of the trial. The call will be available at 866-804-6921 for domestic participants and at 857-350-1667 for international callers (reference passcode 58493295). A replay of the conference call may be accessed beginning approximately two hours after the event and continuing through November 22, 2011 by dialing 888-286-8010 for domestic callers and 617-801-6888 for international callers (reference passcode 24688395).

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