Targacept says trial for ADHDi drug did not meet primary outcome measure

Targacept announced top-line results from a Phase 2 trial of TC-5619 as a treatment for inattentive-predominant attention deficit/hyperactivity disorder, or ADHDi. In the trial, TC-5619 did not meet the primary outcome measure, change from baseline on the inattention subscale of the Conners’ Adult ADHD Rating Scale-Investigator-Rated, after four weeks of treatment versus placebo. Across the study measures, patients in the placebo dose group consistently improved more than patients in the TC-5619 dose groups. TC-5619 exhibited a placebo-like safety and tolerability profile in the study. “We are disappointed that TC-5619 did not meet our goal in this ADHDi study. Based on these results, we have made the determination that we will not pursue further development of TC-5619 in ADHD,” said Mark Skaletsky, Chairman of Targacept’s Board of Directors. “Under these circumstances, we are taking additional steps to more closely align our resources with our current operational plan and emphasize the efficient use of Targacept’s capital. We will limit our investment in our nicotinic pipeline to our ongoing or previously announced clinical programs until the search for a new CEO is successfully completed, and we will implement a further reduction in force."