Axonyx (NASDAQ:AXYX)
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From Jun 2019 to Jun 2024
Axonyx Inc. (NASDAQ: AXYX) announced today completion of
the ascending single dose Phase I trial with Posiphen(TM), in clinical
development for the treatment of Alzheimer's disease progression.
This double-blind, placebo controlled study of Posiphen in healthy
men and women sought to establish well tolerated doses. Posiphen
appears to be well tolerated at single doses up to and including 80mg.
Blood levels of Posiphen associated with this study were higher than
those associated with beneficial effects on beta-amyloid metabolism in
animal models. The build-up of beta-amyloid (A beta) is generally
believed to be causative of the dementia of Alzheimer's disease. No
serious adverse events were reported at any dose level.
During each dosing period in the study, a single dose level of
Posiphen was evaluated. Double-blind Posiphen was administered to
groups of five healthy men and five healthy women, and double-blind
placebo was administered to one man and one woman, for each dosage
level of 10, 20, 40, 80 and 160mg. Blood samples were collected for
pharmacokinetic analyses. Safety assessments, including physical
examinations, clinical laboratory tests, vital signs, ECGs, and the
monitoring of adverse events, were done throughout.
Current treatment of Alzheimer's disease focuses primarily on
acetylcholinesterase inhibition. Posiphen appears to modify the
metabolism of beta-amyloid precursor protein (beta-APP). 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. 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.
The Company anticipates initiating a Phase I ascending multiple
dose study in the near future.
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. The
Company is looking to identify licensing partners to further the
development of Phenserine.
This press release may contain forward-looking statements or
predictions. These statements represent our judgment to date, and are
subject to risks and uncertainties that could materially affect the
Company, including those risks and uncertainties described in the
documents Axonyx files from time to time with the SEC, specifically
Axonyx's annual report on Form 10-K. Specifically, with respect to our
drug candidates Phenserine, Posiphen(TM) and BisNorCymserine, Axonyx
cannot assure that: any preclinical studies or clinical trials,
whether ongoing or conducted in the future, will prove successful, and
if successful, that the results can be replicated; safety and efficacy
profiles of any of its drug candidates will be established, or if
established, will remain the same, be better or worse in future
clinical trials, if any; pre-clinical results related to cognition and
the regulation of beta-APP will be substantiated by ongoing or future
clinical trials, if any, or that any of its drug candidates will be
able to improve the signs or symptoms of their respective clinical
indication or slow the progression of Alzheimer's disease; any of its
drug candidates will support an NDA filing, will be approved by the
FDA or its equivalent, or if approved, will prove competitive in the
market; or that Axonyx will have or obtain the necessary financing to
support its drug development programs. Axonyx undertakes no obligation
to publicly release the result of any revisions to such
forward-looking statements that may be made to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events.