Axonyx: larger Phenserine dose produces results in Alzheimer's patients

By Angela McDaniels

Seattle, Nov. 29 - Axonyx Inc. said an additional analysis of a completed study found that Alzheimer's patients demonstrated a statistically significant benefit over placebo when treated with 15mg of Phenserine twice daily for more than 12 weeks.

Improvement was measured using the cognitive subscale of the Alzheimer's Disease Assessment Scale.

Patients who received Phenserine 10mg twice daily did not show a statistically significant benefit compared to placebo, the company said.

Additionally, this subgroup showed a positive trend towards improvement in the Clinical Interview Based Impression of Change test that approached statistical significance.

While more clinical trials would be required to further confirm the results of this additional analysis, Axonyx believes that they support its stated position that higher doses of Phenserine could be efficacious in treating the signs and symptoms of mild to moderate Alzheimer's disease in future phase 3 trials.

The additional analysis examined a subgroup of patients from its two curtailed phase 3 clinical trials of Phenserine for mild to moderate Alzheimer's disease. The trials were curtailed because primary efficacy analysis of all patients did not demonstrate a statistically significant benefit associated with Phenserine over placebo, the company said.

On Nov. 7, the company said it would not commit further resources to the development of Phenserine. The additional analysis was undertaken as part of the program to identify a partner for the further development of the drug.

Phenserine is a highly selective acetylcholinesterase inhibitor that breaks down a neurotransmitter in the brain important in memory and cognition.

Axonyx Inc. is a New York-based biopharmaceutical company that acquires and develops pharmaceutical compounds for the treatment of central nervous system disorders.

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