WINSTON-SALEM, N.C.--(BUSINESS WIRE)--Targacept, Inc. (NASDAQ: TRGT - News), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics(TM), today announced that its strategic collaborator AstraZeneca has initiated a Phase IIb clinical trial of AZD3480 (TC-1734) in cognitive deficits in schizophrenia, or CDS.
Schizophrenia is a chronic, severe and disabling form of psychosis that, in addition to symptoms such as delusions and hallucinations, is often marked by impairments in cognitive functions such as attention, vigilance, memory and reasoning.
These cognitive impairments play a primary role in the inability of schizophrenic patients to function normally. It has been estimated that there are 8.4 million schizophrenic patients in the major markets worldwide, and that approximately 75% of all schizophrenic patients are cognitively impaired. There is currently no product approved for the treatment of CDS.
“Schizophrenia remains one of the top 10 disabling conditions worldwide for young adults,” said Dawn I. Velligan, Ph.D., Professor at the Department of Psychiatry at the University of Texas Health Science Center at San Antonio and co-director of the Health Science Center’s Division of Schizophrenia and Related Disorders. Velligan explained that although current antipsychotic medications may decrease the frequency of hallucinations and the degree of conviction in false beliefs, which are referred to as “positive” symptoms of schizophrenia, they often do not lead to successful long-term outcomes for schizophrenic patients.
“The development of medications that improve cognition in this illness is extraordinarily important in working toward improvement in the quality of life for individuals with schizophrenia,” Velligan said, noting that cognitive deficits frequently limit the ability of individuals with schizophrenia to learn in rehabilitation programs. “From a clinical perspective, we need to understand whether patients have adequate independent living skills to function in the community.” Velligan said that examples of such skills include taking the bus, keeping one’s living space clean, going to work, remembering to take medication, starting conversations with others, and maintaining friendships.
The CDS trial is a double blind, placebo controlled study being conducted at sites in the United States and Canada. The trial design provides for approximately 400 patients currently taking medication from the class known as atypical anti-psychotics to be randomly assigned to one of three dose groups of AZD3480 or to placebo and to be dosed over a 12-week period. The primary outcome measure of the trial is a cognitive test battery that includes assessments of cognitive functions across nine different domains and was developed in connection with a National Institute of Mental Health initiative known as Measurement and Treatment Research to Improve Cognition in Schizophrenia, or MATRICS. Secondary measures include measures of life functioning, such as performance in day-to-day tasks and social skills. The trial is expected to complete by the end of 2008.
“Research has shown that almost ninety percent of schizophrenics smoke,” said J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept. “One explanation for this high rate of smoking is that schizophrenic patients may be self-medicating with nicotine in order to address the cognitive impairment associated with the disease and thus function better. However, unlike nicotine, which acts non-selectively throughout the central and peripheral nervous system and therefore has an undesirable side effect profile, AZD3480 was designed to target select neuronal nicotinic receptors that studies have shown to play a role in cognition to promote therapeutic effects and limit adverse side effects.”
Bob Holland, Vice President and Head of the Neuroscience Therapy Area, AstraZeneca, added, “As suggested by our two ongoing Phase IIb trials, we are enthusiastic about the cognitive effects of AZD3480 and its potential for treating cognitive deficits in schizophrenia and Alzheimer’s disease, two areas where the unmet medical need is very high.”
AZD3480 has been evaluated to date in 12 clinical trials in approximately 540 subjects. In a previous Phase IIb clinical trial conducted by Targacept in age associated memory impairment, AZD3480 achieved statistically significant results on all of the primary endpoints, reflecting improved cognitive performance by memory-impaired older adults.
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. Its 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 and cognitive deficits in schizophrenia, pain, and depression and anxiety disorders, as well as multiple preclinical programs. Targacept also has strategic alliances with AstraZeneca and GlaxoSmithKline. Additional information about Targacept is available at www.targacept.com.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world’s leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit www.astrazeneca.com.
In Neuroscience, AstraZeneca is dedicated to providing medicines that have the potential to change patients’ lives. The company already markets several products including SEROQUEL® and ZOMIG®. The AstraZeneca neuroscience pipeline includes leading approaches for the treatment of depression and anxiety, schizophrenia, dementia, pain control and anaesthesia.
Forward-Looking Statements
Any statements in this press release about strategies, prospects, plans, expectations or objectives for Targacept, Inc., including, without limitation, statements regarding the progress, timing or scope of the research and development of our product candidates or related regulatory filings or clinical trials, our future operations, financial position, revenues or costs, 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 amount and timing of resources that AstraZeneca devotes to the development of AZD3480 (TC-1734); AstraZeneca’s right in the future to terminate the preclinical research collaboration that we and AstraZeneca are currently conducting prior to the end of the planned four-year term; the position of applicable regulatory authorities with regard to a treatment combination that includes mecamylamine hydrochloride, which is a racemate, as compared to one of its constituent enantiomers such as TC-5214; the results of clinical trials and non-clinical studies and assessments with respect to our current and future product candidates in development; 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 patient enrollment or data analysis; the timing and success of submission, acceptance and approval of regulatory filings; our ability to obtain substantial additional funding and our ability to establish additional strategic collaborations. 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, 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:
Targacept, Inc. Alan Musso, VP and CFO, 336-480-2186 alan.musso@targacept.com or
Linnden Communications Janna Guinen, 781-834-7498 jannag@comcast.net
Source: Targacept, Inc.
