Alzamend Neuro Announces Initiation of Phase I First-in-Human Clinical Trial for AL001 for Dementia Related to Alzheimer’s Disease
September 13 2021 - 6:30AM
Business Wire
Company Achieves Milestone of Dosing First Group of
Participants in Six-Month Comparative Study with Lithium-Delivering
Ionic Cocrystal Oral Treatment
Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an
early clinical-stage biopharmaceutical company focused on
developing novel products for the treatment of neurodegenerative
diseases and psychiatric disorders, today announced that the first
group of healthy participants have been dosed in a six-month Phase
I relative bioavailability study for AL001 for dementia related to
Alzheimer’s disease. The Phase I first-in-human study is for the
purpose of determining potential clinically safe and appropriate
dosing for AL001 in future studies. AL001 is a lithium-delivering
ionic cocrystal under development as an oral treatment for patients
with dementia related to mild, moderate, and severe cognitive
impairment associated with Alzheimer’s disease.
“Advancing AL001 into the clinic as planned marks an important
milestone for Alzamend,” said Stephan Jackman, Chief Executive
Officer of Alzamend. “We believe AL001 could potentially provide
clinicians with a major improvement over current lithium-based
treatments and may constitute a means of treating over 40 million
Americans suffering from Alzheimer’s and other neurodegenerative
diseases and psychiatric disorders. We look forward to completing
the Phase I study and advancing the clinical studies of this
promising potential therapeutic.”
Overview of the Phase I Clinical Study
The Phase I study will investigate the pharmacokinetics (the
movement of drug through the body) of lithium following a single
dose of AL001 (the “study drug”) compared to a typical single dose
of a marketed 300 mg immediate-release lithium carbonate capsule
(the “comparator” – currently indicated to treat mood disorders) in
healthy male and female subjects. The lithium and salicylate
components of AL001 will be given within the amounts already
approved for use in patients. The purpose of the research study is
to test the safety, tolerability, and bioavailability (how much and
when drug gets in the body) of the study drug, AL001, compared to
the currently marketed formulation of the comparator, lithium
carbonate. This is expected to ascertain what AL001 doses should be
given, and how often, in subsequent Phase 2 safety and efficacy
trials involving Alzheimer’s disease patients. At least 24 healthy
male and female human subjects will complete the Phase I trial.
About AL001
AL001 is a patented ionic cocrystal technology delivering
lithium via a therapeutic crystal-engineered combination of
lithium, proline and salicylate, known as AL001 or LiProSal,
through two royalty-bearing exclusive worldwide licenses from the
University of South Florida Research Foundation, Inc.
Based on preclinical data, AL001 treatment prevents cognitive
deficits, depression, and irritability in APPSWE/PS1dE9 mice, and
has shown an improvement of associative learning and memory and
irritability compared with lithium carbonate treatments, supporting
the potential of this lithium formulation for the treatment of
Alzheimer’s disease and psychiatric disorders. Lithium has been
marketed for more than 35 years and human toxicology regarding
lithium use has been well characterized, potentially allowing
Alzamend to rely upon this existing data, potentially reducing the
regulatory burden for safety data.
About Alzamend Neuro
We are an early clinical-stage biopharmaceutical company focused
on developing novel products for the treatment of neurodegenerative
diseases and psychiatric disorders, including Alzheimer’s disease.
Our mission is to rapidly develop and market safe and effective
treatments. Our current pipeline consists of two novel therapeutic
drug candidates, AL001 – a patented ionic cocrystal technology
delivering lithium via a therapeutic crystal-engineered combination
of lithium, proline and salicylate, and AL002 – a patented
therapeutic mutant peptide sensitized cell-based therapeutic
vaccine that is targeted to augment the ability of a patient’s
immune system to combat Alzheimer’s disease. Both of our product
candidates are licensed from the University of South Florida
Research Foundation, Inc. pursuant to royalty-bearing exclusive
worldwide licenses.
Forward-Looking Statements
This press release contains “forward looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These forward-looking statements generally include
statements that are predictive in nature and depend upon or refer
to future events or conditions, and include words such as
“believes,” “plans,” “anticipates,” “projects,” “estimates,”
“expects,” “intends,” “strategy,” “future,” “opportunity,” “may,”
“will,” “should,” “could,” “potential,” or similar expressions.
Statements that are not historical facts are forward-looking
statements. Forward-looking statements are based on current beliefs
and assumptions that are subject to risks and uncertainties.
Forward-looking statements speak only as of the date they are made,
and Alzamend undertakes no obligation to update any of them
publicly in light of new information or future events. Actual
results could differ materially from those contained in any
forward-looking statement as a result of various factors. More
information, including potential risk factors, that could affect
Alzamend’s business and financial results are included in
Alzamend’s filings with the U.S. Securities and Exchange
Commission. All filings are available at www.sec.gov and on
Alzamend’s website at www.Alzamend.com.
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