�Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing a new year of drugs known as NNR Therapeutics�, today proclaimed that it has initiated a Phase 2b clinical trial of TC-5214 as an augmentation therapy in subjects with Major Depressive Disorder (MDD). TC-5214 is a wide spectrum neural nicotinic sense organ (NNR) antagonist and represents a hopeful new mechanism in growing for the treatment of MDD.
"The millions of patients distress from depression who do not respond well to the presently available first-line therapies need help," said Dr. Madhukar H. Trivedi, Professor and the Director of the Mood Disorders Research Program and Clinic at the University of Texas Southwestern Medical Center at Dallas and 1 of the principal investigators in the National Institute of Mental Health's large-scale STAR*D study. "There is a great unmet medical need for effective second and third line treatments with novel mechanisms of action to augment existing therapies and improve clinical outcomes for these patients. I am very enthusiastic about the potential for NNR-targeted compounds and other novel mechanisms to serve this need."
The design of the Phase 2b trial of TC-5214 includes two phases. In the first stage, subjects diagnosed with MDD will receive citalopram hydrobromide, a selective serotonin reuptake inhibitor (SSRI), for 8 weeks to determine the extent of therapeutic response. Subjects world Health Organization have non responded well based on predefined criteria would be randomized into the double blind sec phase of the run and receive either TC-5214 or placebo, together with continued citalopram therapy, for an extra eight weeks. It is expected that approximately 560 subjects will participate in the first phase of the run and close to 220 subjects will be randomized into the moment phase of the trial. The master endpoint of the trial run is change from baseline during the second stage of the trial as measured by the Hamilton Depression Rating Scale. The trial volition also collect information on a variety of lower-ranking safety and efficacy measures. The trial is planned to be conducted at sites in the United States and India.
"The initiation of this Phase 2b clinical trial, just four months after TC-5214 initially entered the clinic, reflects non only our enthusiasm for its curative promise but also our ability to execute against a very aggressive development plan," aforesaid J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept. "We believe that the favourable preclinical visibility of TC-5214, combined with the positive results from our premature Phase 2 clinical trial run of mecamylamine as an augmentation treatment for MDD, bode well for TC-5214's potential for clinical success."
About TC-5214
It is well known that depressive symptoms canful result from an overstimulation of NNRs and early receptors in the brainiac that ar activated by the neurotransmitter acetylcholine. Accordingly, compounds capable of inhibiting the action of these overstimulated receptors, known as antagonists, may be expected to have antidepressant effects. In a prior Phase 2 clinical trial conducted by Targacept, subjects with MDD whose treatment with citalopram was augmented with mecamylamine hydrochloride showed greater improvement on symptoms of depression than subjects world Health Organization received continued citalopram treatment and placebo.
TC-5214 is the S(+) enantiomer of mecamylamine hydrochloride. TC-5214 has exhibited an overall therapeutical profile superior to mecamylamine in presymptomatic models of depression and anxiety (Lippiello et al., accepted for publication in CNS Neuroscience & Therapeutics), a determination consistent with laboratory studies showing TC-5214 to more effectively inhibit the body process of the alpha4beta2 NNR.
About MDD
According to The National Institute of Mental Health, MDD is the star cause of disability in the United States for people between the ages 15 and 44. The NIMH estimates that close to 14.8 million American adults suffer from MDD.
The Sequenced Treatment Alternatives to Relieve Depression, or STAR*D, study undertaken by the National Institute of Mental Health between 2001 and 2006 showed the inadequacy of currently available therapies for MDD. In the low phase of the STAR*D study, roughly 2,800 persons with MDD were given citalopram for 12 to 14 weeks. Only about one-third of the participants reached remission and about 10-15 percent more than responded, only did not reach remission. The second phase of the STAR*D study evaluated the effects of augmentation with a new medication or switch to a different discussion for participants who did not respond or only when responded partially to citalopram. Approximately unrivalled in little Joe of these participants reached remission. These findings induce been cited as highlight the need for more broadly effective antidepressant treatments (Rush, et al., NEJM Volume 354:1231-1242, March 23, 2006 Number 12).
About Targacept
Targacept is a clinical-stage biopharmaceutical troupe that discovers and develops NNR Therapeutics�, a new class of drugs for the treatment of central nervous organisation diseases and disorders. Targacept's product candidates selectively modulate neuronal nicotinic receptors that serve as key regulators of the nervous system to promote therapeutic effects and limit adverse side effects. Targacept has product candidates in development for Alzheimer's disease, cognitive dysfunction in schizophrenic disorder, pain and depression, as well as multiple presymptomatic programs. Targacept also has a cognition-focused collaboration with AstraZeneca and a strategic alliance with GlaxoSmithKline. Targacept's news releases are available on its website at www.targacept.com.
Forward-Looking Statements
Statements in this press waiver that are not strictly historical in nature, including, without limitation, statements regarding the advancement, timing or scope of the research and development of TC-5214 or related regulatory filings or clinical trials, including the number of subjects to be included in the on-going Phase 2b trial, the benefits that may be derived from TC-5214, our plans, expectations, future operations, financial place, revenues, costs or expenses, constitute "advanced statements" within the substance of the Private Securities Litigation Reform Act of 1995. Actual results crataegus laevigata differ materially from those expressed or implied by forward-looking statements as a result of various important factors, including risks and uncertainties relating to: the results of clinical trials and non-clinical studies and assessments with respect to TC-5214, including whether the results of our realized Phase 2 clinical test of racemic mecamylamine as an augmentation treatment for MDD and positive findings in preclinical studies of TC-5214 ar predictive of the results of the ongoing Phase 2b clinical trial and any future clinical trials of TC-5214; the conduct of such trials, studies and assessments, including the performance of third parties that we engage to execute them and difficulties or delays in the completion of subject enrollment or information analysis; the timing and success of submission, acceptance and favorable reception of regulative filings with respect to TC-5214; our ability to obtain, hold and enforce patent security for TC-5214; and our ability to obtain material additional financing. These and other risks and uncertainties that crataegus laevigata impact real results ar described in greater detail under the heading "Risk Factors" in our most recent Annual Report on Form 10-K and in other filings that we make with the Securities and Exchange Commission. As a consequence of the risks and uncertainties, the ts or events indicated by the forward-looking statements may non occur. We caution you not to place undue reliance on any modern statement. In addition, whatsoever forward-looking statements in this release constitute our views only as of the date of this outlet 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, we specifically disclaim any obligation to do so, except as required by applicable constabulary.
Source
Alan Musso
Targacept, Inc., VP and CFO
www.targacept.com
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