AstraZeneca announces ‘inconclusive’ top-line AZD3480 results

AstraZeneca and Targacept have announced “inconclusive” top-line results from their phase IIb trial of AZD3480 (TC-1734) in Alzheimer’s disease.

The companies said the results were not conclusive because the primary outcome measure was not significant for either AZD3480 or donepezil, as the data was impacted by improvements in the placebo group.

Improvements were however observed in the secondary outcome measures of ADCS-GVIC and MMSE in the Sirroco trial.

The overall safety and tolerability profile for AZD3480 were comparable to those for placebo, while fewer gastrointestinal adverse effects were observed than in patients who received donepezil.

Following the publication of results, the companies said they would make a further analysis of the full dataset and engage in planned discussions with medical experts.

J Donald deBethizy, president and chief executive officer of Targacept, said: “While we had hoped for a more conclusive overall outcome, we believe the Sirocco trial provides further support for the clinical rationale for AZD3480.”

He added the results strengthen the scientific foundation of its NNR Therapeutics pipeline.

In December 2006, AstraZeneca announced plans to continue the development of AZD3480 in patients with Alzheimer’s disease, as well as cognitive defects in patients with schizophrenia, with the firm giving Targacept a $20 million (10.2 million pounds) milestone payment as a result.