Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, has completed recruitment of patients in the Phase IIb study of TC-5619 as a treatment for negative symptoms and cognitive dysfunction in schizophrenia. The company expects to report top-line results from the study by the end of 2013. TC-5619 is a highly selective modulator of the alpha7 neuronal nicotinic receptor.
“I would like to thank the patients, study sites and investigators who have helped us reach this important milestone in the development of TC-5619 as a potential new treatment for schizophrenia,” said Dr. Stephen A. Hill, Targacept’s President and Chief Executive Officer. “Current schizophrenia therapies primarily impact positive symptoms of schizophrenia, leaving the negative symptoms and cognitive dysfunction largely untreated. A new and effective treatment that addresses this medical need would be critically important for the millions of schizophrenia patients unable to function in society.”
The ongoing Phase IIb study is a double blind, placebo controlled, randomized, parallel group trial being conducted at sites in Eastern Europe and the United States. The primary outcome measure is the Scale for the Assessment of Negative Symptoms (SANS). Key secondary outcome measures include the CogState Schizophrenia Battery (composite score), a computerized test battery, and the University of California, San Diego Performance-Based Skills Assessment, Brief Version. The study is designed to randomize 456 patients with stable schizophrenia who are taking a fixed dose of an atypical antipsychotic. The study includes a 4-week screening period, followed by a 24-week treatment period during which patients receive one of two doses of TC-5619 (5mg or 50mg) or placebo once daily.
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