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news.Shares in CNS-focused biopharmaceutical firm Axonyx have plummeted over 60% after the company's Alzheimer's disease treatment candidate, Phenserine, proved ineffective in a phase III trial.
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In the trial, Phenserine, which is in development for mild to moderate Alzheimer’s disease (AD), failed to result in a statistically significant improvement over placebo for the protocol’s primary endpoints.
While Phenserine-treated patients performed better in the ADAS-cog and CIBIC assessments – the study’s primary endpoints at almost all time points – the outcome was potentially confounded by a better than expected ADAS-cog response in the placebo-treated patients.
A preliminary review of the adverse events has revealed no safety or tolerability concerns associated with Phenserine treatment.
Axonyx said it is continuing to further analyze the data and will use this valuable information to optimize the trial designs in the currently planned program.
Phenserine is currently undergoing testing in a phase IIb trial to evaluate its anticipated ability to lower levels of beta-amyloid precursor protein and beta-amyloid n the plasma and cerebrospinal fluid, which may lead to a slowing of disease progression. The results of the phase III trial are expected before the end of March 2005.