Targacept ADHD candidate fails to meet primary endpoints in Ph II study

In a second disappointment this year, US drug developer Targacept (Nasdaq: TRGT) said yesterday that top-line results from a Phase II trial of TC-5619 as a treatment for inattentive-predominant attention deficit/hyperactivity disorder (ADHDi) showed that the drug trial 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. The company’s shares fell more than 11% to $4.31 in morning trading on Monday.

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, the company said.

“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.