Clinical-stage biopharmaceutical company Targacept has completed patient recruitment in the Phase 2b schizophrenia study of TC-5619.
TC-5619, a highly selective modulator of the alpha7 neuronal nicotinic receptor, is developed as a treatment for negative symptoms and cognitive dysfunction in schizophrenia.
Targacept president and chief executive officer Dr. Stephen Hill said existing schizophrenia therapies primarily impact positive symptoms of schizophrenia, while cognitive dysfunction and negative symptoms are left mostly 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," Hill added.
The ongoing Phase 2b double blind study being conducted at sites in Eastern Europe and the US is designed to randomise 456 patients with stable schizophrenia, who are taking a fixed dose of an atypical antipsychotic.
The placebo-controlled, randomised, parallel group trial’s 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 computerised test battery, and the University of California, San Diego Performance-Based Skills Assessment, Brief Version.
A four-week screening period is followed by a treatment period of 24 weeks during which patients receive one of two doses of TC-5619 (5mg or 50mg) or placebo once daily.
The company expects to report top-line results from the study by the end of 2013.
Photo: Image showing brain areas more active in controls than in schizophrenia patients during a working memory task during a fMRI study. Two brain slices are shown. Image: Courtesy of Kim J, Matthews NL, Park S.