AstraZeneca and Targacept, Inc announced top-line results from a phase-IIb clinical trial of AZD3480 (TC-1734) conducted by AstraZeneca in cognitive dysfunction in schizophrenia (CDS), known as the HALO trial.

AZD3480 did not meet the trial's criteria for statistical significance on the primary endpoints, improvement on various cognitive domains measured by the IntegNeuro computerized test battery. AZD3480 was generally well tolerated in the study. AstraZeneca and Targacept do not expect to progress AZD3480 into phase-III studies for CDS.

In addition to the HALO trial, AstraZeneca and Targacept previously announced top-line results from a phase-IIb study of AZD3480 in mild to moderate Alzheimer's disease, known as the Sirocco trial, and are currently evaluating AZD3480 in a phase-II exploratory study in attention deficit/hyperactivity disorder (ADHD) in adults. A decision by AstraZeneca with respect to potential further development of AZD3480 in Alzheimer's disease or ADHD is now expected in the first half of 2009, pending completion of the adult ADHD study and other ongoing evaluations.

"While this trial outcome did not meet our objectives, we continue to pursue medicines that target neuronal nicotinic receptors (NNRs) with Targacept to treat cognitive disorders," said Bob Holland, vice president and head of the Neuroscience Therapy Area, AstraZeneca.

Targacept and AstraZeneca also announced that the lead compound arising out of the parties' preclinical research collaboration is poised to enter the clinic. AstraZeneca plans by the end of 2008 to initiate a phase-I trial of AZD1446 (TC-6683), a product candidate selective for the alpha4beta2 NNR. Under the terms of the parties' collaboration agreement, AstraZeneca has agreed to make a $2.0 million milestone payment to Targacept.

"We are obviously disappointed that AZD3480 did not meet our goals in the HALO trial," commented J Donald deBethizy, president and chief executive officer of Targacept. "We thank AstraZeneca for its commitment to AZD3480 and its investment in this pioneering work in an emerging area considered to be critical in the treatment of patients with schizophrenia. We look forward to continuing our cognition-focused collaboration with AstraZeneca."

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services.

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.