Targacept and AstraZeneca Initiate Clinical Trial of AZD3480 in Adult ADHD
"In our previous clinical trials of AZD3480, the compound has demonstrated compelling attentional effects," said J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept. "We expect this well-designed pilot study to provide valuable insight that will facilitate future development planning."
The primary objective of the double blind, placebo controlled, crossover trial is to assess the efficacy of two different dose strengths of AZD3480 in adult subjects diagnosed with ADHD. The crossover trial design provides for each subject to serve as its own control by receiving both dose strengths of AZD3480 as well as placebo, with the treatment periods separated by a washout period. The trial, which is planned to enroll 24 subjects, is being conducted at Fletcher Allen Health Care, an affiliate of the University of Vermont College of Medicine, under the direction of Drs. Paul Newhouse and Alexandra Potter.
Targacept and AstraZeneca are collaborating on the execution of the trial, with Targacept responsible for managing and funding the trial and AstraZeneca responsible for providing the clinical trial materials and communicating with regulatory authorities.
Clinical studies of AZD3480 previously conducted in approximately 540 subjects, including both healthy volunteers and cognitively impaired older adults, indicate the beneficial effects of AZD3480 on cognitive function generally and attention and memory in particular. AZD3480 is currently being evaluated in two Phase 2b clinical trials, one in mild to moderate Alzheimer's disease (the "Sirocco" trial) and one in cognitive dysfunction in schizophrenia (the "HALO" trial). These trials, which are together planned to enroll approximately 925 patients, are being conducted by AstraZeneca and are expected to be completed in the second half of 2008.
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 to promote therapeutic effects and limit adverse side effects. Targacept has product candidates in development for Alzheimer's disease, cognitive dysfunction in schizophrenia, pain and depression, as well as multiple preclinical 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.
Statements in this press release that are not purely historical in nature, including, without limitation, statements regarding the progress, timing or scope of the research and development of AZD3480 (TC-1734) or related regulatory filings or clinical trials, including the number of subjects enrolled, the benefits that may be derived from AZD3480 (TC-1734), or our plans, expectations, future operations, financial position, revenues, costs or expenses, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may 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 amount and timing of resources that AstraZeneca devotes to, and the significant control that AstraZeneca has over, the development of AZD3480 (TC-1734); the risk that successful results in clinical trials of AZD3480 (TC-1734) in a particular condition characterized by one degree of cognitive impairment may not be predictive of successful results in clinical trials of AZD3480 (TC-1734) in a condition characterized by more severe cognitive impairment or in cognitive impairment resulting from a different condition; the results of clinical trials and non-clinical studies and assessments of AZD3480 (TC-1734); the conduct of such trials, studies and assessments, including the performance of third parties engaged to execute them and difficulties or delays in the completion of subject enrollment or data analysis; and the timing and success of submission, acceptance and approval of regulatory filings with respect to AZD3480 (TC-1734). These and other risks and uncertainties are 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 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, we specifically disclaim any obligation to do so, except as required by applicable law.
Posted: June 2008