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AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Alzheimer's Disease
Date:9/15/2008

owed an improvement on ADCS-CGIC (0.2 point improvement) and the MMSE (1.0 point improvement). Neither donepezil nor AZD3480 showed improvement in any domain of the Cognitive Drug Research computerized test battery in the pooled dataset of all subjects.

AZD3480 exhibited an overall safety and tolerability profile comparable to placebo in the trial, with fewer gastrointestinal-related adverse events (diarrhea, nausea and vomiting) than donepezil.

Analyses of the full dataset from the Sirocco trial are ongoing. AstraZeneca and Targacept plan to discuss the data with leading medical experts and to present and publish more detailed results over the coming months. A decision by AstraZeneca with respect to potential further development of AZD3480 is expected in December 2008.

"While we had hoped for a more conclusive overall outcome, we believe the Sirocco trial provides further support for the clinical rationale for AZD3480 by demonstrating improvement on both ADCS-CGIC, an accepted scale that reflects improvement in everyday activities, and the widely used MMSE cognitive assessment, as well as a favorable safety and tolerability profile," said J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept. "These findings also strengthen the scientific foundation for our pipeline of NNR Therapeutics. We thank AstraZeneca for its execution of this trial and investment in the broad development of AZD3480."

In addition to Alzheimer's disease, AZD3480 is currently being evaluated in a Phase IIb trial in cognitive dysfunction in schizophrenia (the "HALO" trial), as well as a Phase II exploratory study in adult attention deficit/hyperactivity disorder. Top-line results from the cognitive dysfunction in schizophrenia trial are expected by the end of 2008.

About the Study

The Phase IIb Sirocco trial was conducted by AstraZeneca under the terms of an exclusive global license and research collaboration agreement. The trial
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SOURCE AstraZeneca
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