Alzamend Neuro to Present Non-Clinical Data Update at the Society of Toxicology 2025 Annual Meeting and ToxExpo
December 18 2024 - 8:00AM
Business Wire
Presentation Topic is the Pharmacokinetics of AL001, a
Lithium Salicylate/L-Proline Co-crystal, as a Potentially
Beneficial Lithium Sparing Treatment for Bipolar Disorder Type 1,
Alzheimer’s Disease, Major Depressive Disorder and Post-Traumatic
Stress Disorder
Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a
clinical-stage biopharmaceutical company, focused on developing
novel products for the treatment of Alzheimer’s disease
(“Alzheimer’s”), bipolar disorder (“BD”), major
depressive disorder (“MDD”) and post-traumatic stress
disorder (“PTSD”), today announced it will have a poster
presentation at the Society of Toxicology (“SOT”) Annual
Meeting and ToxExpo, being held from March 16-20, 2025, in Orlando,
Florida.
“Our poster presentation at SOT in 2025 with data from our
non-clinical study: Comparing Brain and Plasma Lithium Exposures
between AL001 and Lithium Carbonate in Alzheimer’s Transgenic Mice,
demonstrates the potential of AL001 to enhance brain-specific
lithium delivery while minimizing systemic exposure in an
Alzheimer’s disease mouse model, guiding development of enhanced
lithium effectiveness and safety in human diseases,” said Stephan
Jackman, Chief Executive Officer of Alzamend. “Following successful
results from this study and our Phase I and IIA trials, AL001 is
positioned for five Phase II trials in partnership with
Massachusetts General Hospital in 2025. These trials aim to
redefine lithium therapy across neurodegenerative and
neuropsychiatric conditions by leveraging a lower-dose,
high-efficacy approach anticipated to qualify for the U.S. Food and
Administration 505(b)(2) approval pathway.”
Abstract 3266/H393 – Poster presentation: Title:
Pharmacokinetics of AL001, Lithium Salicylate/L-Proline
Co-crystal: A Potentially Beneficial Lithium Sparing Treatment for
Bipolar Disorder Type 1 (BD1), Alzheimer’s Disease (AD), Major
Depressive Disorder (MDD) and Post-traumatic Stress Disorder
(PTSD) Session Title: Pharmaceutical Safety and Drug
Discovery Session Date and Time: Monday, March 17, 2025;
9:15AM ET – 11:45AM ET Session Location: Orange County
Convention Center, ToxExpo Hall Presenting Author: Darrell
Sawmiller, Ph.D, Assistant Professor, Center of Excellence for
Aging & Brain Repair, University of South Florida, Tampa, FL,
USA
Summary: No Undue Adverse
Effects: Both treatments had no negative impact on the
mice's body weight or clinical signs during the treatment period.
Reduced Systemic Exposure: AL001
showed lower plasma lithium levels than lithium carbonate, reducing
the risk of adverse systemic effects, suggesting an expansion for
safety of lithium’s therapeutic index. Enhanced Brain Penetration: AL001 showed
consistently higher lithium concentrations in brain tissues,
particularly at lower doses, compared to lithium carbonate.
Targeted Brain Structures: The study
found that different brain regions absorb and retain lithium
differently. This means treatments can potentially be tailored to
target specific brain areas, allowing for more precise treatment of
various brain-related conditions when applied in human studies.
Further information can be found at
https://www.toxicology.org/events/am/AM2025/index.asp.
About AL001 Non-Clinical Study
The study involved administering AL001, a good manufacturing
practices-quality active pharmaceutical ingredient (“API”)
to 5XFAD mice, a recognized model for Alzheimer’s research, to
compare its effects against lithium carbonate, a U.S. Food and Drug
Administration approved and marketed API. Mice received either high
or low doses scaled to humans of both AL001 and lithium carbonate
over a 14-day period to observe pharmacokinetic steady-state drug
conditions. On the 15th day, the mice were analyzed to assess how
the treatments affected lithium concentrations in different brain
regions and in their plasma. The results mentioned in the summary
highlight the potential clinical advantages of AL001 for conditions
like Alzheimer’s, BD, MDD and PTSD at low doses. By reducing the
systemic burden, AL001 could lessen the risk of side effects such
as thyroid and kidney complications often associated with extant
lithium therapies. This positions AL001 as a promising candidate
for safer long-term treatment options, without the need for routine
blood lithium monitoring. This innovation is specifically designed
to address the needs of fragile populations, such as elderly and
Alzheimer’s patients, by offering a potentially more efficient and
safer alternative to existing treatments.
About Alzamend Neuro
Alzamend Neuro is a clinical-stage biopharmaceutical company
focused on developing novel products for the treatment of
Alzheimer’s, BD, MDD and PTSD. 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 combination of lithium, salicylate and L-proline, and
ALZN002 - 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.
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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