Targacept Initiates Phase 2 Study of TC-5619 in Cognitive Dysfunction in Schizophrenia
Winston-Salem, North Carolina
December 10, 2009
Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics (TM), today 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 (TM).
“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.
About Cognitive Dysfunction in Schizophrenia
Schizophrenia is a chronic, severe and disabling form of psychosis. In addition to symptoms such as delusions, hallucinations, the inability to disregard familiar stimuli (sometimes referred to as sensory gating), disorganized speech, grossly disorganized or catatonic behavior and prolonged loss of emotion, feeling, volition or drive, schizophrenia is often marked by impairment in cognitive functions, such as attention, vigilance, memory and reasoning. These cognitive impairments play a primary role in the inability of schizophrenic patients to function normally. The market research firm Business Insights estimated that there were approximately 7.9 million people with schizophrenia in the world’s seven major pharmaceutical markets in 2007. It has been estimated that up to 75% of persons with schizophrenia are cognitively impaired. There is currently no drug approved in the United States or Europe specifically for cognitive dysfunction in schizophrenia.
About Targacept
Targacept is a clinical-stage biopharmaceutical company that discovers and develops NNR Therapeutics (TM), a new class of drugs for the treatment of central nervous system diseases and disorders, in support of its vision of building health and restoring independence for patients. Targacept’s product candidates selectively modulate neuronal nicotinic receptors that serve as key regulators of the nervous system to promote therapeutic effects and limit adverse side effects. Targacept has clinical-stage product candidates in development for major depressive disorder, attention deficit/hyperactivity disorder, Alzheimer’s disease and cognitive dysfunction in schizophrenia, as well as multiple preclinical programs. Targacept recently announced a global collaboration and license agreement with AstraZeneca for the late-stage investigational product TC-5214 for the treatment of major depressive disorder. Targacept also has a cognition-focused collaboration with AstraZeneca and a strategic alliance with GlaxoSmithKline. Targacept’s news releases are available on its website at www.targacept.com.
Forward-Looking Statements
This press release includes “forward-looking statements” made under the provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements other than statements of historical fact regarding, without limitation: the progress, scope or duration of the development of TC-5619, such as the design, endpoints or subject population for or the number of subjects to be included in the Phase 2 clinical trial of TC-5619, the timing for completion of or availability of results from the Phase 2 clinical trial of TC-5619 or the indication(s) for which TC-5619 may be developed; the benefits that may be derived from TC-5619; or Targacept’s plans, expectations or future operations, financial position, revenues, costs or expenses. Actual results may differ materially from those expressed or implied by forward-looking statements as a result of various important factors, including, without limitation, risks and uncertainties relating to: the conduct and results of the Phase 2 clinical trial of TC-5619, including the performance of third parties engaged to execute such trial, any changes that may be made to the applicable protocol and difficulties or delays in the completion of subject enrollment or data analysis; and the timing and success of submission, acceptance and approval of regulatory filings. These and other risks and uncertainties are described in greater detail under the heading “Risk Factors” in Targacept’s most recent Annual Report on Form 10-K, in its subsequently filed Quarterly Reports on Form 10-Q and in other filings that it makes with the Securities and Exchange Commission. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Targacept cautions you not to place undue reliance on any forward-looking statement.
In addition, any forward-looking statement in this press release represents Targacept’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Targacept disclaims any obligation to update any forward-looking statement, except as required by applicable law.
NNR Therapeutics (TM) and Pentad (TM) are trademarks of Targacept, Inc. Any other service marks, trademarks and trade names appearing in this press release are the properties of their respective owners.
Targacept Contacts:
Alan Musso, VP and CFO
Targacept, Inc.
Tel: (336) 480-2186
Email: alan.musso@targacept.com
Michelle Linn
Linnden Communications
Tel: (508) 362-3087
Email: linnmich@comcast.net
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