Targacept Initiates Phase I Clinical Trial of TC-2216

Announced that it has initiated a Phase I clinical trial of TC-2216, its product candidate for the treatment of depression and anxiety disorders.

WINSTON-SALEM, NC, USA | Jan 08, 2007 |
Targacept, Inc. (Nasdaq: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics™, today announced that it has initiated a Phase I clinical trial of TC-2216, its product candidate for the treatment of depression and anxiety disorders.

The trial is designed to evaluate the safety and tolerability of TC-2216 and to assess its pharmacokinetic profile. The trial is a double-blind, placebo-controlled crossover study, with sequential ascending single oral doses administered to healthy male volunteers.

TC-2216 is a novel compound discovered using Targacept’s proprietary drug design platform known as Pentad™. The compound targets 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-2216 selectively inhibits the alpha4beta2 NNR to modulate the release of neurotransmitters that are involved in mood regulation. In preclinical studies, TC-2216 showed greater potency than and anti-depressant effects comparable to selective serotonin reuptake inhibitors and tricyclics, which are commonly used treatments for depression, as well as anxiety-relieving effects.

Targacept currently plans to develop TC-2216 as an oral monotherapy. In November, the company announced positive top line results from a Phase II clinical trial of TRIDMAC™, a treatment combination comprised of mecamylamine hydrochloride as an augmentation therapy to citalopram hydrobromide, in patients who did not respond adequately to citalopram alone. Mecamylamine hydrochloride binds non-selectively to various NNR subtypes, but there is a body of scientific evidence that suggests that its anti-depressant activity is derived through its antagonism at the alpha4beta2 NNR.

“Depression is a highly debilitating illness, and millions of people who suffer with it are not gaining adequate relief from existing therapies,” said J. Donald deBethizy, Ph.D., Targacept’s President and Chief Executive Officer. “The results of our TRIDMAC trial not only substantiate the promise of the NNR mechanism in the treatment of depression and other mood disorders, but also further bolster our enthusiasm for the potential of TC-2216.”

About Targacept
Targacept is a clinical-stage biopharmaceutical company that discovers and develops NNR Therapeutics™, 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 http://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-2216 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: the results of non-clinical studies and assessments and clinical trials with respect to TC-2216 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.

SOURCE: Targacept, Inc

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