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news.Axonyx shares have risen over 2% after the company announced that it will continue to enroll patients in a phase IIb study of Phenserine in Alzheimer's disease despite interim results showing that the drug failed to produce statistically significant results.
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The trial, named AX-CL-06a, is designed to evaluate the effects of Phenserine tartrate (PT) on cerebrospinal fluid (CSF) levels of beta-amyloid (A(beta) 1- 42) and other biomarkers in mild to moderate Alzheimer’s disease (AD) patients.
The presence of toxic beta-amyloid in the brains of AD patients is considered by many experts to be a key pathological event in the causation as well as the progression of AD. A reduction of beta-amyloid levels could correlate to a reduced progression of AD.
The interim analysis demonstrated that none of the numerical differences between the treatment groups achieved statistical significance. However, there was sufficient information to conclude that enrollment to the 15mg dose group was justified, the company revealed.
Completion of patient enrollment of this trial is expected in the second quarter of 2005 with final results in the last quarter 2005.
“While these results met the predefined criteria for continuing enrollment at the higher dose and we believe are encouraging, further data are required before definitive conclusions can be drawn,” stated Dr Gosse Bruinsma, president and CEO of Axonyx. “Successful completion of this trial will remain a priority for the company.”