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Targacept Phase IIb trial in Alzheimer’s disease fails to show superiority of TC-1734 over Donepezil

Targacept, a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, has announced top-line results from a Phase 2b monotherapy clinical trial of TC-1734 as a treatment for mild to moderate Alzheimer’s disease.

In the trial, TC-1734 did not meet the objective of showing superiority to donepezil, the marketed medication most often prescribed for Alzheimer’s disease, after 52 weeks of treatment.

The trial did not include a placebo arm and was not designed to determine whether TC-1734 is equivalent to donepezil. The co-primary endpoints for the study were measures of cognitive function and global function. Consistent with previous clinical results, TC-1734 exhibited a benign safety and tolerability profile.

"We are disappointed for Alzheimer’s disease patients and their families. We designed a rigorous study to provide a definitive answer on whether TC-1734 could be a better treatment option than the current standard of care in what has been a very difficult disease area for the development of novel therapeutics. Based on these results, we do not intend to invest in further development of TC-1734," said Dr. Stephen A. Hill, Targacept’s President and Chief Executive Officer.

"I want to thank the investigators, patients and my colleagues at Targacept for their efforts."

Analyses of the full dataset from the trial are ongoing and Targacept plans to present and publish more detailed results over the coming months.