Targacept Initiates Clinical Development of TC-5214 as Augmentation Therapy for Major Depressive Disorder
Winston-Salem, North Carolina
March 17, 2008
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 1 clinical trial of TC-5214. Targacept is developing TC-5214 as an augmentation therapy for major depressive disorder (MDD). A Phase 2 clinical proof of concept trial is planned for later in 2008.
The Phase 1 trial, which is being conducted in the United States, is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TC-5214 in healthy volunteers. TC-5214 is the S(+) enantiomer of the racemate mecamylamine hydrochloride, a broad spectrum NNR antagonist. In preclinical studies, TC-5214 has exhibited a better overall safety and efficacy profile than mecamylamine.
“We are delighted by the entry of TC-5214 into the clinic and enthusiastic about its strong therapeutic potential,” said J. Donald deBethizy, Ph.D., Targacept’s President and Chief Executive Officer. “The NNR mechanism represents an exciting new paradigm in the development of treatments for depression, a particularly critical health issue that demands a novel therapeutic approach. The positive results across multiple endpoints in our TRIDMAC trial underscore the potential for success in future trials of TC-5214.”
Targacept previously conducted a Phase 2 trial of racemic mecamylamine in 184 patients with major depressive disorder who did not respond adequately to first-line treatment with the selective serotonin reuptake inhibitor citalopram. In that trial, known as the TRIDMAC (TM) trial, patients whose continued citalopram treatment was augmented with racemic mecamylamine showed greater improvement on symptoms of depression than patients who received continued citalopram treatment and placebo. A poster presentation of the results of the TRIDMAC trial will be accessible from the TC-5214 page in the Product Pipeline section on Targacept’s website, www.targacept.com, until at least June 30, 2008.
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. 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 product candidates in development for Alzheimer’s disease and cognitive deficits in schizophrenia, pain and depression, and multiple preclinical programs. Targacept also has a 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
Statements in this press release that are not purely historical in nature, including, without limitation, statements regarding the progress, timing or scope of the research and development of TC-5214 or related regulatory filings or clinical trials, the benefits that may be derived from TC-5214, our plans, expectations, future operations, financial position, revenues, costs or expenses, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those expressed or implied by forward-looking statements as a result of various important factors, including risks and uncertainties relating to: the results of clinical trials and non-clinical studies and assessments with respect to TC-5214, including whether the results of our completed Phase 2 clinical trial of racemic mecamylamine as an augmentation treatment for major depression are predictive of the results of future clinical trials of TC-5214; the conduct of such trials, studies and assessments, including the performance of third parties that we engage to execute them and difficulties or delays in the completion of patient enrollment or data analysis; the timing and success of submission, acceptance and approval of regulatory filings; and our ability to obtain substantial additional funding. These and other risks and uncertainties that may impact actual results are described in greater detail under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and in other filings that we make 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. We caution you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statements in this release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, except as required by applicable law.
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: michelle@linndencom.com
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