Targacept Completes Recruitment in Phase 2b Trial of TC-1734 in Mild to Moderate Alzheimer’s Disease

  Targacept Completes Recruitment in Phase 2b Trial of TC-1734 in Mild to
  Moderate Alzheimer’s Disease

Business Wire

WINSTON-SALEM, N.C. -- April 29, 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-1734 as a treatment for
mild to moderate Alzheimer’s disease. Targacept expects to report top-line
results from the study in mid-2014. TC-1734 is a modulator of the alpha4beta2
neuronal nicotinic receptor subtype.

“While the pursuit of an effective new treatment for Alzheimer’s disease has
been historically challenging, the unmet medical need is both enormous and
growing,” said Dr. Stephen A. Hill, Targacept’s President and Chief Executive
Officer. “Our thanks go to the patients, study sites and investigators who are
collaborating with us in the effort to find a new medicine for this
devastating disease.”

The ongoing Phase 2b study is a double blind, randomized, parallel group trial
evaluating TC-1734 head-to-head against donepezil, the marketed medication
most often prescribed for Alzheimer’s disease. The study, designed to
randomize approximately 300 patients, is being conducted at sites
predominantly in Eastern Europe and also in the United States. The Alzheimer’s
Disease Assessment Scale-cognitive subscale (ADAS-Cog) and the Clinician
Interview-Based Impression of Change Plus Caregiver Input (CIBIC-(+)) are
co-primary endpoints of the study, with the Alzheimer's Disease Cooperative
Study Activities of Daily Living Inventory (ADCS-ADL) replacing CIBIC-(+) as a
co-primary endpoint for European regulatory purposes. The study includes a
3-week screening period, followed by a 12-month treatment period during which
patients receive a fixed dose of TC-1734 (30mg) or donepezil once daily.

About Alzheimer’s Disease

Alzheimer’s disease is a progressive, degenerative disorder that attacks the
brain’s nerve cells, or neurons, resulting in loss of memory, thinking and
language skills, and behavioral changes. The market research firm Decision
Resources estimated that there were approximately 20 million people with
Alzheimer’s disease in the world’s seven major pharmaceutical markets (U.S.,
France, Germany, Italy, Spain, United Kingdom and Japan) in 2011. According to
the Alzheimer’s Association, the number of people age 65 and over afflicted in
the United States is projected to nearly triple from 5 million to 13.8 million
by 2050.

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-1734 in mild
to moderate Alzheimer’s disease; the medical benefits of TC-1734; 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-1734, 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; 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 any forward-looking statement 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, 336-480-2186
SVP and CFO
alan.musso@targacept.com
or
Linnden Communications
Michelle Linn, 508-362-3087
linnmich@comcast.net
 
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