Targacept Completes Recruitment in Phase 2b Schizophrenia Trial of TC-5619

  Targacept Completes Recruitment in Phase 2b Schizophrenia Trial of TC-5619

Business Wire

WINSTON-SALEM, N.C. -- April 18, 2013

Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company
developing novel NNR Therapeutics™, today announced that it has completed
recruitment of patients in the Phase 2b study of TC-5619 as a treatment for
negative symptoms and cognitive dysfunction in schizophrenia. The company
expects to report top-line results from the study by the end of 2013. TC-5619
is a highly selective modulator of the alpha7 neuronal nicotinic receptor.

“I would like to thank the patients, study sites and investigators who have
helped us reach this important milestone in the development of TC-5619 as a
potential new treatment for schizophrenia,” said Dr. Stephen A. Hill,
Targacept’s President and Chief Executive Officer. “Current schizophrenia
therapies primarily impact positive symptoms of schizophrenia, leaving the
negative symptoms and cognitive dysfunction largely untreated. A new and
effective treatment that addresses this medical need would be critically
important for the millions of schizophrenia patients unable to function in
society.”

The ongoing Phase 2b study is a double blind, placebo controlled, randomized,
parallel group trial being conducted at sites in Eastern Europe and the United
States. The primary outcome measure is the Scale for the Assessment of
Negative Symptoms (SANS). Key secondary outcome measures include the CogState
Schizophrenia Battery (composite score), a computerized test battery, and the
University of California, San Diego Performance-Based Skills Assessment, Brief
Version. The study is designed to randomize 456 patients with stable
schizophrenia who are taking a fixed dose of an atypical antipsychotic. The
study includes a 4-week screening period, followed by a 24-week treatment
period during which patients receive one of two doses of TC-5619 (5mg or 50mg)
or placebo once daily.

About Negative Symptoms and Cognitive Dysfunction in Schizophrenia

Schizophrenia is a chronic, severe and disabling form of psychosis. The
disease generally includes three domains, positive symptoms, negative symptoms
and cognitive dysfunction. The negative symptoms and cognitive dysfunction
play a primary role in the inability of many schizophrenic patients to
function normally. The market research firm Decision Resources estimated that
there were approximately 4.7 million people with schizophrenia in the world’s
seven major pharmaceutical markets in 2011. Estimates as to the prevalence of
schizophrenia patients who suffer from negative symptoms vary, and it has been
estimated that up to 75% of patients with schizophrenia are cognitively
impaired. There is currently no drug approved in the United States or Europe
specifically for the treatment of negative symptoms of schizophrenia or
cognitive dysfunction in schizophrenia.

About Targacept

Targacept is developing a diverse pipeline of innovative NNR Therapeutics™ for
difficult-to-treat diseases and disorders of the nervous system. NNR
Therapeutics selectively modulate the activity of specific neuronal nicotinic
receptors, unique proteins that regulate vital biological functions that are
impaired in various disease states. Targacept’s clinical pipeline includes
multiple Phase 2 product candidates, all representing first-in-class
opportunities. Targacept leverages its scientific leadership and diverse
pipeline to attract significant collaborations with global pharmaceutical
companies. For more information, please visit www.targacept.com.

TARGACEPT

Building Health, Restoring Independence®

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 timing for reporting of
top-line results from Targacept’s Phase 2b clinical trial of TC-5619 in
negative symptoms and cognitive dysfunction in schizophrenia; or Targacept’s
plans, expectations or future operations, financial position, revenues, costs
or expenses. Actual results, performance or experience may differ materially
from those expressed or implied by any forward-looking statement as a result
of various important factors, including without limitation Targacept’s
critical accounting policies and risks and uncertainties relating to: the
conduct and results of the ongoing Phase 2b clinical trial of TC-5619,
including the performance of third parties engaged to execute such trial,
delays resulting from any changes to the applicable protocols and difficulties
or delays in the completion of subject enrollment or data analysis; whether
positive findings from Targacept’s completed clinical trial of TC-5619 in
patients with schizophrenia will be replicated in the ongoing clinical trial
of TC-5619; Targacept’s ability to establish additional strategic alliances,
collaborations or licensing or other comparable arrangements on favorable
terms; Targacept’s ability to protect its intellectual property; and the
timing and success of submission, acceptance and approval of regulatory
filings. Risks and uncertainties that Targacept faces are described in greater
detail under the heading “Risk Factors” in Targacept’s most recent Annual
Report on Form 10-K 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™ and Building Health, Restoring Independence^® are trademarks
or service marks of Targacept, Inc. Any other service marks, trademarks and
trade names appearing in this press release are the properties of their
respective owners.

Contact:

Targacept, Inc.
Alan Musso, SVP and CFO
336-480-2186
alan.musso@targacept.com
or
Linnden Communications
Michelle Linn, 508-362-3087
linnmich@comcast.net
 
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