Axonyx continues phenserine evaluation
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Axonyx believes a subgroup analysis of failed Phase III trials for its Alzheimer's therapy phenserine supports its position that higher doses of the treatment "could potentially be efficacious in treating the signs and symptoms of mild to moderate AD in future potential Phase III trials," the firm says Nov. 29. In a subgroup of patients receiving phenserine 15 mg twice daily, a statistically significant benefit over placebo was seen in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). "This additional analysis was recently completed as part of the program to identify a partner for the further development of phenserine," Axonyx says. Axonyx initially announced disappointing results for phenserine in February, then again in September (Pharmaceutical Approvals Monthly October 2005, In Brief)...
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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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