AstraZeneca and Targacept announced the enrollment of the first patient in their Phase 3 development program 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/norepinephrine reuptake inhibitor (SNRI). The two companies 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. 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. 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.
TC-5214 is a nicotinic channel blocker that has unique properties in modulating the alpha4beta2 NNR subtype. By inhibiting overstimulated NNR receptors, compounds such as TC-5214 may be expected to have antidepressant effects.