Alzamend Neuro Receives FDA “Study May Proceed” Letter for Phase 1 Clinical Study Under Its Investigational New Drug Application for AL001 for Dementia Related to Alzheimer’s Disease
July 28 2021 - 3:07PM
Business Wire
Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an
early clinical-stage stage biopharmaceutical company focused on
developing novel products for the treatment of neurodegenerative
diseases and psychiatric disorders, today announced receipt of U.S.
Food and Drug Administration (“FDA”) study may proceed
letter for a Phase 1 study under the Company’s Investigational New
Drug application for AL001, a lithium-based ionic cocrystal oral
therapy for patients with dementia related to mild, moderate, and
severe cognitive impairment associated with Alzheimer’s
disease.
“We are grateful to receive this timely, favorable response from
the FDA to initiate a Phase 1 trial with AL001,” said Stephan
Jackman, the Chief Executive Officer of Alzamend. “We are advancing
the process and expect that the first patient will be dosed in
September 2021.”
About AL001
AL001 is a patented ionic cocrystal technology delivering a
therapeutic 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.
With our product candidates, we aim to bring treatments or cures to
market at a reasonable cost as quickly as possible. Our current
pipeline consists of two novel therapeutic drug candidates, AL001 –
a patented ionic cocrystal technology delivering a therapeutic
combination of lithium, proline and salicylate, and AL002 – a
patented method using a mutant peptide sensitized cell as a
cell-based therapeutic vaccine that seeks to restore the ability of
a patient’s immunological 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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Email: Info@Alzamend.com or call: 1-844-722-6333
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