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

WINSTON-SALEM, N.C.--(BUSINESS WIRE)-- 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.


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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.

Targacept, Inc.
Alan Musso, 336-480-2186
Linnden Communications
Michelle Linn, 508-362-3087

KEYWORDS:   United States  North America  North Carolina


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