Axonyx reports Phenserine associated with significant amyloid reduction in phase 1 trial

By Lisa Kerner

Erie, Pa., Feb. 14 - Axonyx Inc. reported a significant reduction in the plasma levels of beta-amyloid 1-42 (A beta-42) in healthy human subjects treated with Phenserine for 35 days.

Phenserine is a selective inhibitor of acetylcholinesterase (AChEI), an enzyme that breaks down a neurotransmitter important to memory and cognitive function, according to a company news release. It also has the ability to lower levels of the peptide beta-amyloid, which may lead to alterations in the brain that can cause Alzheimer's disease.

Six healthy men and six healthy women were enrolled in the multiple-dose phase 1 study and treated with Phenserine 10 mg twice daily for 28 days and Phenserine 15 mg twice daily for an additional week. Samples were collected according to a pre-defined pharmacokinetic sampling schedule.

There were no unexpected safety or tolerability concerns noted in the 12 healthy test subjects, the company said.

Axonyx said the lack of a placebo group calls for caution when interpreting these results, and they are consistent with effects of Phenserine on A beta-42 observed in pre-clinical, placebo-controlled studies.

Therefore, the company considers these results supportive of Phenserine's dual mechanisms of action, differentiating it as a potential treatment for Alzheimer's disease.

Axonyx previously reported interim analyses of its phase 2b beta amyloid trial, which appeared to show an effect of Phenserine on levels of beta amyloid. However, the variability of data in that study and the size of that trial could not support the potential of a statistically significant outcome, Axonyx said.

Axonyx is a New York-based biopharmaceutical company engaged in the acquisition and development of proprietary pharmaceutical compounds for the treatment of central nervous system disorders.

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