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Targacept, Inc. (NASDAQ: TRGT) today announced top-line results from a Phase 2 trial of TC-5619 as a treatment for inattentive-predominant attention deficit/hyperactivity disorder (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 (CAARS-INV), 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. Targacept is immensely grateful for the contributions of each of our employees, and we can only make this difficult decision based on our commitment to maximizing the future potential of the company’s assets.”
About the Phase 2 Trial
The Phase 2 study was a double blind, placebo controlled, randomized parallel group trial conducted at 13 sites in the United States. The primary outcome measure was change from baseline on the inattention subscale of the Conners’ Adult ADHD Rating Scale-Investigator-Rated (CAARS-INV), after four weeks of treatment versus placebo. The study randomized 175 patients with ADHDi, ages 18 to 65, of which 153 completed the study. The study design provided for a four-week screening period after which patients were randomized into one of three cohorts and received either placebo or one of two doses of TC-5619 (5mg or 25mg) once daily for four weeks in a ratio of 2:1:1 (placebo: low dose: high dose). The study concluded with a two-week follow-up period. The study also assessed the safety and tolerability of TC-5619.