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. wellbutrin.
“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.