Targacept (Nasdaq: TRGT) has completed recruitment of patients for the Phase 2b study of its schizophrenia treatment, the Winston-Salem biopharmaceutical firm announced last week.
The company has developed TC-5619 as a treatment for the negative symptoms and cognitive dysfunction caused by schizophrenia.
Targacept expects promising results by the end of the year.
The ongoing Phase 2b 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 four-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.
“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 Stephen Hill, M.D., Targacept’s president and CEO. “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.”
(C) NC Biotech Center