AstraZeneca, Targacept commence enrollment in TC-5214 Phase 3 clinical development for MDD

AstraZeneca and Targacept, Inc., today announced the enrollment of the first patient in the Phase 3 clinical development program for TC-5214, a nicotinic channel blocker. The Phase 3 program, referred to as the Renaissance Program, is designed to support the planned second half of 2012 filing of a new drug application with the U.S. Food and Drug Administration for TC-5214 as an adjunct treatment for major depressive disorder (MDD) in patients with an inadequate response to first-line therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin/norephinephrine reuptake inhibitor (SNRI). A Marketing Authorisation Application in Europe is projected for 2014.

AstraZeneca and Targacept have designed the Renaissance Program to include two fixed dose Phase 3 studies and two flexible dose Phase 3 studies to evaluate the efficacy and tolerability of TC-5214 as an adjunct treatment in patients with an inadequate response to SSRI or SNRI therapy. The Renaissance Program also includes a double blind, placebo controlled long-term safety study in which patients would receive TC-5214 or placebo for up to one year. All studies in the Renaissance Program are on track to initiate this year.

Each of the fixed dose and flexible dose Phase 3 studies includes an open label first phase in which patients diagnosed with MDD receive one of seven marketed SSRIs or SNRIs for eight weeks to determine the extent of therapeutic response. For each study, patients who do not respond adequately based on predefined criteria are to be randomized into a double blind, placebo controlled second phase to receive a fixed dose (in the case of the fixed dose trials) or a flexible dose that may escalate (in the case of the flexible dose trials) of TC-5214 or placebo, twice daily, while continuing the SSRI or SNRI therapy for an additional eight weeks. The primary outcome measure for each study is change from double blind baseline for TC-5214 on the Montgomery-Asberg Depression Rating Scale (MADRS) as compared to placebo.