Axonyx (NASDAQ:AXYX)
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Axonyx Inc. (NASDAQ: AXYX) announced today the
completion of its second Phase I study with Posiphen(TM) in clinical
development for the treatment of Alzheimer's 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'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.
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; Axonyx will be able to successfully out-license any of its
drug candidates; Axonyx will be able to successfully in-license any
additional compounds; or that Axonyx will have or obtain the necessary
financing to support its drug development programs. Axonyx cannot
assume that it will be successful with regard to identifying a (sub-)
licensing partner for any of its compounds. 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.