Axonyx Announces Completion of the Multiple-Dose Phase I Study of Posiphen(TM)
Monday May 15, 4:15 pm ET
NEW YORK--(BUSINESS WIRE)--May 15, 2006--Axonyx Inc. (NASDAQ: AXYX - News) announced today the completion of its second Phase I study with Posiphen(TM) in clinical development for the treatment of Alzheimer's disease progression.
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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's disease and its progression. No serious adverse events were reported at any dose level in this second Phase I study.
This multiple ascending-dose study examined the effects of Posiphen 20, 40 and 60mg given four times daily, for a period of 7, 7 and 10 days respectively. On the first and last day of each dosing period one single dose of Posiphen was given. Each dose period was completed and evaluated for safety and tolerance before the next higher dose level was initiated. Each cohort was composed of a different set of 16 subjects, comprised of 12 who received Posiphen and 4 who received placebo, with equal numbers of males and females in each.
The necessary detailed safety, pharmacokinetic and pharmacodynamic analyses are ongoing. Based on this favourable clinical outcome, Axonyx is evaluating plans regarding the further clinical development steps for Posiphen.
Posiphen(TM)
Current treatment of Alzheimer's disease focuses primarily on acetylcholinesterase inhibition. A major pathological hallmark of AD is the appearance of senile plaques that are primarily composed of aggregated forms of beta-amyloid (A beta) derived from beta-APP. Posiphen appears to modify the metabolism of beta-amyloid precursor protein (beta-APP). Soluble forms of A beta have been shown to cause significant toxicity in vitro and in vivo and hence represent a target for drug development in AD treatment.
The acetylcholinesterase (AChE) inhibitor Phenserine, which is currently in development by the Company mainly for the symptomatic treatment of mild to moderate AD, and its positive isomer, Posiphen, have both been found to significantly reduce beta-APP and A beta in cell culture systems and animals. As a consequence of its apparent lack of AChE inhibitory activity, Posiphen may be administered in relatively high doses. Such high doses may result in potentially meaningful reductions in A beta in Alzheimer's disease patients.
About Axonyx
Axonyx Inc. is a U.S.-based biopharmaceutical company engaged in the acquisition and development of proprietary pharmaceutical compounds for the treatment of Central Nervous System disorders. The Company currently has three compounds in development for Alzheimer's disease, namely Phenserine - a potential symptomatic and disease progression treatment of mild to moderate Alzheimer's disease (AD), Posiphen(TM) - a potential disease progression treatment for AD now in Phase I, and BisNorCymserine (BNC) - a potential symptomatic treatment of severe AD now in pre-Investigational New Drug (IND) stage.
