Axonyx, Inc. announced the completion of its second Phase I study with Posiphen in clinical development for the treatment of Alzheimer disease progression.
This double-blind, placebo-controlled multiple ascending-dose safety and pharmacokinetic study of Posiphen in healthy volunteers sought to establish well tolerated doses.
The initial review of the clinical adverse event data appears to be generally consistent with the results of the earlier single ascending dose phase I study that suggested that the mean Posiphen blood levels associated with well tolerated doses in humans are higher than those associated with potentially beneficial effects on beta-amyloid metabolism in animal models. The build-up of beta-amyloid (Aa) is generally believed to be causative of the dementia of Alzheimer disease and its progression. No serious adverse events were reported.