ARTICLE | Clinical News

Targacept falls on depression data

December 21, 2011 1:52 AM UTC

Targacept Inc. (NASDAQ:TRGT) fell $2.79 (36%) to $4.99 on Tuesday after TC-5214 missed the primary endpoint vs. placebo in the Phase III RENAISSANCE 2 trial to treat major depressive disorder in patients with an inadequate response to first-line therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin/norephinephrine reuptake inhibitor (SNRI). Targacept and partner AstraZeneca plc (LSE:AZN; NYSE:AZN) said twice-daily doses of TC-5214 as adjunct therapy did not significantly improve Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline to week eight vs. placebo. The double-blind, flexible-dose, U.S. and Indian trial enrolled 319 patients with MDD. TC-5214 is an S-enantiomer of mecamylamine hydrochloride, a broad spectrum non-competitive nicotinic receptor antagonist.

In November, the partners said TC-5214 as an adjunct therapy missed the primary endpoint in the Phase III RENAISSANCE 3 trial. The Phase III RENAISSANCE program of TC-5214 consists of four efficacy trials and a Phase III safety trial. Data from the remaining three trials are expected in 1H12. On a previous conference call, Targacept said it expects that a "positive outcome in two of RENAISSANCE's efficacy studies should be sufficient to support regulatory approval in the U.S." The partners plan to submit an NDA to FDA for TC-5214 in 2H12. ...