BioCentury
ARTICLE | Clinical News

TC-5619: Development discontinued

December 23, 2013 8:00 AM UTC

Targacept discontinued development of TC-5619 to treat negative symptoms and cognitive dysfunction in patients with schizophrenia after top-line data from a double-blind, international Phase IIb trial in 477 patients with schizophrenia showed that once-daily 5 and 50 mg oral TC-5619 each missed the primary endpoint of improving SANS scores from baseline to week 24 vs. placebo. Both doses of TC-5619 also missed the secondary endpoints of improving CSB and UPSA-Brief scores from baseline to week 24 vs. placebo. The trial enrolled patients with stable psychotic symptoms who were receiving a fixed dose of an atypical antipsychotic to receive placebo or once-daily 5 or 50 mg TC-5619 for 24 weeks as an add-on therapy. Targacept also said it discontinued development of TC-5619 to treat Alzheimer's disease (AD), for which it was in Phase I testing, based on the lack of improvement in measures of cognitive function seen in the schizophrenia trial. Last year, Targacept discontinued development of TC-5619 to treat ADHD after the compound missed the primary endpoint in a Phase II trial in adults with inattentive-predominant ADHD (see BioCentury, Sept. 24, 2012). ...