Targacept, Inc. Begins Phase II Clinical Trial In Acute Post-Operative Pain

WINSTON-SALEM, N.C., Dec. 19 /PRNewswire-FirstCall/ -- Targacept, Inc. , a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics(TM), today announced that it has initiated a Phase II clinical trial of TC-2696, its product candidate for the treatment of acute post-operative pain. The proof of concept trial is designed to evaluate the analgesic effects of TC-2696 following dental surgery.

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The randomized, double-blind, single-dose trial is being conducted in the United States and is expected to enroll approximately 150 molar extraction patients. The trial includes five arms, 10, 25 and 50mg TC-2696, ibuprofen (400mg) as a positive control and placebo.

TC-2696, a novel compound discovered using Targacept's proprietary drug design platform known as Pentad(TM), modulates specific neuronal nicotinic receptors (NNRs), a class of receptors found in the central nervous system that play a critical role in regulating nervous system activity. TC-2696 binds selectively to the alpha4beta2 NNR and is believed to act by blocking the transmission of pain signals to the brain. Targacept has previously conducted a Phase I single ascending dose clinical trial of TC-2696. A Phase I multiple ascending dose clinical trial is ongoing.

"A number of studies in the scientific literature have shown the analgesic effects of compounds that act on the alpha4beta2 NNR," said J. Donald deBethizy, Ph.D., Targacept's President and Chief Executive Officer. "The promise of TC-2696 in this area is reflected both in the effects on pain relief that we have observed in our early clinical testing of this compound and its activity in a variety of preclinical models. TC-2696 is one of several NNR-selective product candidates in our product pipeline with potential to be a first-in-class therapeutic to address a significant unmet need."

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 activity 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 is located in Winston-Salem, North Carolina. For more information about Targacept, please visit www.targacept.com

Forward-Looking Statements

Any statements in this press release about expectations, plans and prospects for Targacept, Inc., including, without limitation, statements regarding the progress, timing and scope of research and development of TC- 2696 and related regulatory filings and 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: AstraZeneca's right to terminate our collaboration agreement based on the results of the safety and product characterization studies and all other available information with respect to TC-1734 (AZD3480); the results of non-clinical studies and assessments and clinical trials with respect to TC-2696 or our other current and future product candidates in development; the conduct of clinical trials, including the performance of third parties that we engage to execute the trials and difficulties or delays in the completion of patient enrollment or data analysis; and the timing and success of submission, acceptance and approval of regulatory filings. These and other risks and uncertainties are described in greater detail under the heading "Risk Factors" in our most recent Quarterly Report on Form 10-Q 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.

CONTACT: Alan Musso, VP and CFO of Targacept, Inc., +1-336-480-2186, oralan.musso@targacept.com; or Michelle Linn of Linnden Communications,+1-508-419-1555, or linnmich@comcast.net, for Targacept, Inc.

Web site: http://www.targacept.com//