Phenserine Phase III Studies Proceed After Alzheimer’s Drug Fails Pivotal Trial
This article was originally published in Pharmaceutical Approvals Monthly
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Axonyx phenserine failed Phase III data
Axonyx continues to evaluate its development program for the acetylcholinesterase inhibitor phenserine in Alzheimer's disease following its Sept. 20 announcement of further negative Phase III results. Twelve-week data from two curtailed Phase III trials show no statistically significant benefit over placebo. The results follow a similar finding in an earlier Phase III trial, announced in February (1Pharmaceutical Approvals Monthly February 2005, p. 17). At that time, Axonyx had planned to recruit 900 patients total for the more recent studies. However, when the first Phase III study failed to show efficacy, "patient recruitment for these two ongoing Phase III trials was halted." A total of 255 patients were enrolled in the two more recent trials. Axonyx notes that its Phase IIb trial evaluating phenserine's ability to lower beta-amyloid precursor protein is ongoing...
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