Targacept Initiates Phase 2 Study of TC-5619 in Cognitive Dysfunction in Schizophrenia
News Dec 11, 2009
Targacept, Inc. has announced that it has initiated a Phase 2 clinical proof of concept trial of TC-5619 in cognitive dysfunction in schizophrenia.
TC-5619 is a novel small molecule that is highly selective for the alpha7 neuronal nicotinic receptor, or NNR, and was discovered by Targacept scientists using Targacept’s proprietary drug discovery platform known as Pentad™.
“We believe that currently available treatment options do not adequately address the dramatic impact schizophrenia has on cognition for millions of patients. Medications capable of improving attention and reasoning in these patients are needed to improve their quality of life,” said J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept.
“The scientific literature is replete with evidence of the key role that the alpha7 NNR plays both in cognitive function and in the psychoses characteristic of schizophrenia. TC-5619 is highly selective for the alpha7 NNR and has to date shown little or no interaction with the 5-HT3 receptor, which is known to be associated with significant limiting side effects that have served as an obstacle to the successful development of other alpha7 NNR modulators.”
The multi-center Phase 2 clinical proof of concept trial is a double blind, placebo controlled, randomized, parallel group study to be conducted in the United States and India. The trial is planned to include up to 200 subjects who are currently taking an approved medication from the drug class known as atypical anti-psychotics. It is expected that approximately 50% of subjects will be tobacco users and approximately 50% will be non-tobacco users.
The trial design provides for subjects to be randomly assigned to one of three dose groups of TC-5619 or to placebo and dosed over a 12-week period. The primary efficacy outcome measure of the trial is change from baseline on the Groton Maze Learning item of the CogState Schizophrenia Test Battery, a computerized battery of neuropsychiatric tests that assess specific cognitive domains, on each of three measurement dates as compared to placebo.
Targacept expects that the Phase 2 trial of TC-5619 could be completed by the end of 2010. Following completion of the trial, Targacept’s strategic collaborator AstraZeneca has the right to license TC-5619 on terms specified in the parties’ December 2005 collaboration agreement.