Winston-Salem, North Carolina Jul 24, 2007
Targacept, Inc. (Nasdaq: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics(TM), today presented positive research findings at the 2007 Summer Meeting of the British Association for Psychopharmacology (BAP). The data suggest that an add-on treatment of mecamylamine hydrochloride, a broad spectrum nicotinic antagonist, improved symptoms of depression in patients who were inadequate responders to first-line citalopram therapy.
“NNR antagonists like mecamylamine may be an important new therapy for treating this group of depressed patients with high unmet medical need,” said Geoffrey C. Dunbar, M.D., Vice President of Clinical Development and Regulatory Affairs at Targacept. “The promise of the NNR mechanism as augmentation is particularly encouraging in light of the STAR*D study, which found that less than a third of patients became symptom free with first-line citalopram therapy.” Dunbar also noted that per the Sheehan Irritability Scale (SIS), the data showed a statistically strong advantage in the improvement of irritability, which is a common feature of depression. The SIS is a clinical rating scale used to assess the extent to which emotional symptoms such as irritability, frustration, edginess, moodiness, anger with self, anger with others, and temper are present.
Mecamylamine represents a new class of promising antidepressant medications that target the brain’s neuronal nicotinic receptors (NNRs). Targacept’s depression program also includes TC-5214, one of the enantiomers of mecamylamine hydrochloride and a preclinical product candidate as an augmentation therapy, and TC-2216, a product candidate as a monotherapy for depression and anxiety disorders that is currently in an ongoing Phase I clinical trial.
The Sequenced Treatment Alternatives to Relieve Depression study, or STAR*D, funded by the National Institute of Mental Health (NIMH) was the nation’s largest study of treatment-resistant depression. According to the NIMH, if a patient does not respond to a particular treatment, his or her options generally consist of trying an augmentation therapy or switching to another medication. Currently, there are no approved augmentation therapies for depression.
The Targacept study included an open label citalopram hydrobromide phase and a subsequent double blind, placebo controlled phase in which the effects of mecamylamine taken with citalopram, a treatment combination known as TRIDMAC(TM), were evaluated in patients who did not respond adequately to citalopram alone. In the trial, the treatment combination of mecamylamine and citalopram was generally well tolerated. Also, patients showed greater improvement on symptoms of depression and irritability when augmented with mecamylamine, as compared to placebo. Patients for the trial were recruited from nine outpatient facilities, one in the U.S. and eight in India. Of the 472 subjects screened, 450 entered the trial and 192 were randomized to double blind medication.
The BAP poster is available on the Targacept website at www.targacept.com.
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 anxiety disorders, as well as multiple preclinical programs. Targacept is located in Winston-Salem, North Carolina. Targacept’s news releases are available on its website at www.targacept.com.
Forward Looking Statements
Any statements in this press release about strategies, prospects, plans, expectations or objectives for Targacept, Inc., including, without limitation, statements regarding the progress, timing and scope of the research and development of our product candidates or related regulatory filings or clinical trials, and all other statements that are not purely historical in nature, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “promise,” “continue,” “ongoing” and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those expressed or implied by forward-looking statements as a result of various important factors, including our critical accounting policies and risks and uncertainties relating to: the position of applicable regulatory authorities with regard to a treatment combination that includes mecamylamine hydrochloride, which is a racemate, as compared to one of its constituent enantiomers such as TC-5214; the results of clinical trials and non-clinical studies and assessments with respect to mecamylamine hydrochloride, TC-5214, TC-2216 and our other current and future product candidates in development; 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; our ability to obtain substantial additional funding; our ability to establish additional strategic collaborations; and our ability to obtain, maintain and enforce patent and other intellectual property protection for our product candidates and discoveries. These and other risks and uncertainties 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, whether as a result of new information, future events or otherwise, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
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Contacts:
Alan Musso, VP and CFO
Targacept, Inc.
Tel: (336) 480-2186
Email: alan.musso@targacept.com
Michelle Linn
Linnden Communications
Tel: (508) 419-1555
Email: linnmich@comcast.net