Statistically Significant Results on All Three Primary Endpoints in AAMI Trial
WINSTON-SALEM, N.C., May 17 /PRNewswire-FirstCall/ -- Targacept, Inc. (Nasdaq: TRGT) today announced positive results from its Phase II clinical trial of TC-1734 (AZD3480) in age associated memory impairment (AAMI). TC-1734 (AZD3480), a highly selective alpha4 beta2 neuronal nicotinic receptor (NNR) agonist, was discovered using Pentad(TM), a sophisticated computer-based molecular design platform developed by Targacept scientists. The compound is planned for development as a treatment for Alzheimer’s disease and cognitive deficits in schizophrenia under a collaboration agreement between Targacept and AstraZeneca (NYSE: AZN).
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The Phase II AAMI clinical trial was ongoing when Targacept and AstraZeneca entered into their collaboration agreement in December 2005 and was completed independently by Targacept under the terms of the agreement. The trial was a multi-center, randomized, double-blind, placebo-controlled, dose-finding study conducted at 16 U.S. sites. Subjects (n = 193) were between the ages of 50 and 80, reported memory impairment without evidence of dementia, neurological illness or other medical cause and scored at least one standard deviation below the mean established for young adults on the Wechsler Memory Scale - Revised, Paired Associate Learning Test. Each subject received 25mg or 50mg doses of TC-1734 (AZD3480) or placebo once daily for 16 weeks. Routine safety measures were taken, and cognitive performance was assessed using a computerized test battery developed by Cognitive Drug Research (CDR) on the day before the initial dosing and again at weeks eight and 16. The three co-primary endpoints in the trial were change from baseline on the Power of Attention (Atten) and Episodic Memory (Mem) factors from the CDR test battery and composite score on subject global impression (SGI), an overall cognitive change self-rating scale, in each case as compared to placebo at the end of the 16-week dosing period.
TC-1734 (AZD3480) achieved statistically significant results on all three primary endpoints in the 50mg TC-1734 dose group in both the per protocol population (Atten p = 0.010, Mem p = 0.030, SGI p = 0.008) and intent to treat population (Atten p = 0.014, Mem p = 0.029, SGI p = 0.015). In the 25mg TC-1734 dose group, the compound achieved a statistically significant result on the power of attention endpoint (p = 0.023 in the per protocol population and p = 0.025 in the intent to treat population). In addition, TC-1734 (AZD3480) was generally well tolerated in the trial as compared to placebo. A poster of results from this trial presented in Geneva, Switzerland at the recently held 9th International Geneva/Springfield Symposium on Advances in Alzheimer Therapy is available on the Investor Relations section of Targacept’s website (http://www.targacept.com).
“We are extremely pleased with the results from this well designed trial of TC-1734 (AZD3480). These data may generate renewed optimism for many older persons who are challenged by memory and attention impairments that make their ordinary daily living tasks and social interactions difficult,” said J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept.
“We are pleased that Targacept has completed this trial, AstraZeneca looks forward to continuing development on this important compound,” said Bob Holland, Vice President and Head of the Neuroscience Therapy Area, AstraZeneca.
Commenting on the results, Dr. Keith Wesnes, developer of the CDR test battery, said, “The effects of TC-1734 (AZD3480) on cognitive performance in this AAMI trial are among the most robust that I have seen. The magnitude of the effect observed in this trial suggests that TC-1734 (AZD3480) may have improved cognitive function of these older subjects to performance levels of persons 10 years younger, based on normative data gathered by CDR over many years.”
Dr. Jeff Williamson, MHS, MD, Assistant Professor in the Department of Medicine, Section on Geriatric Medicine and Gerontology at Wake Forest University School of Medicine and a principal investigator in the trial, remarked, “I see people in the clinic every day who are faced with the reality and challenges of age associated memory impairment. Cognitive decline in our aging population is a serious unmet need, and the fact that the subjects in this trial themselves perceived improved cognitive performance is particularly noteworthy. I am enthused by the potential of Targacept’s compound.”
Background
Age associated memory impairment, or AAMI, describes a common condition characterized by gradual memory loss or other cognitive impairment that generally occurs with normal aging. Although estimates of the prevalence of AAMI in the elderly vary greatly because of varying methodologies and definitions of AAMI, AAMI may affect as many as 38% of people over age 65 or approximately 13 million people in the United States based on 2000 census data.
About Targacept
Targacept is a biopharmaceutical company engaged in the design, discovery and development of a new class of drugs to treat multiple diseases and disorders of the central nervous system by selectively targeting neuronal nicotinic receptors, or NNRs. NNRs are found on nerve cells throughout the nervous system and serve as key regulators of nervous system activity. Targacept’s product candidates are designed to selectively target specific NNR subtypes to promote therapeutic effects and limit adverse side effects. Targacept has a marketed product, Inversine(R) (mecamylamine hydrochloride), product candidates in development for Alzheimer’s disease and cognitive deficits in schizophrenia, pain and depression, and multiple preclinical programs. Targacept’s news releases are available on its website at http://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 over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. 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, dementia, stroke, pain control and anaesthesia. For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Targacept, Inc., including, without limitation, statements regarding the possible therapeutic benefits of TC-1734, the progress, timing and scope of the development program for TC-1734 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,” “continue,” “ongoing” and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including risks and uncertainties relating to: the amount and timing of resources that AstraZeneca devotes to its conduct of safety and product characterization studies of TC-1734 and to any subsequent development of TC-1734; 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; the conduct of clinical trials of TC-1734, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; the results of clinical trials of TC-1734 and whether such results will be indicative of results obtained in later clinical trials. These and other risks are described in greater detail under the heading “Risk Factors” in our Registration Statement on Form S-1 (File No. 333-131050) and in other filings that we make with the Securities and Exchange Commission. If one or more of these factors materialize, the outcome of one or more of these uncertainties is unfavorable to us or any of our assumptions that underlie a forward-looking statement proves incorrect, our actual results, performance or experience may vary materially from any future results, performance or experience expressed or implied by these forward-looking statements.
In addition, the statements in this release reflect our expectations and beliefs as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.
SOURCE Targacept, Inc.
