Alzamend Neuro Announces Positive Topline Data from Phase 1 First-in-Human Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s
18 December 2021 - 1:00AM
Business Wire
Data shows that AL001 is bioequivalent to the marketed
lithium carbonate product and the shapes of the lithium plasma
concentration versus time curves are similar
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 it has
received positive topline data from its Phase 1 clinical trial for
AL001. The purpose of the Phase 1 first-in-human study was to
determine the pharmacokinetics, safety and tolerability of AL001 so
as to target doses for a planned Phase 2 multiple ascending dose
study in Alzheimer’s patients. AL001 is a lithium-delivery system;
it is a lithium-salicylate-L-proline engineered ionic co-crystal
under development as an oral treatment for patients with dementia
related to mild, moderate, and severe cognitive impairment
associated with Alzheimer’s disease.
During this Phase 1 first-in-human trial, participants received
a single dose of AL001 containing lithium in an amount equivalent
to 150 mg lithium carbonate; this is the dose proposed by the
inventors as likely appropriate for Alzheimer’s treatment when
given three times daily. Currently, marketed immediate-release
lithium carbonate 300 mg are given three times daily; for example,
lithium carbonate 300 mg three times daily is a dose commonly used
for bipolar affective disorders. It can be difficult to set the
appropriate dose of lithium carbonate and other lithium products
due to the small margin between effective and toxic blood levels
and to avoid side effects or inadequate treatment outcomes.
“This is amazing news,” said Stephan Jackman, Chief Executive
Officer of Alzamend. “We see the possibility of providing the
benefits from lithium at up to 50% of the currently approved
lithium carbonate dosage, with the potential for better outcomes
and with elimination of the need for lithium therapeutic drug
monitoring. Moreover, the data confirms AL001’s potential as a
replacement of the current lithium-based treatments and may provide
a treatment to the over 40 million Americans suffering from
Alzheimer’s and other neurodegenerative diseases and psychiatric
disorders.”
Dose-adjusted relative bioavailability analyses of the rate and
extent of lithium absorption indicate that AL001 is bioequivalent
to the marketed 300 mg lithium carbonate product and the shapes of
the lithium plasma concentration versus time curves are similar.
AL001 salicylate plasma concentrations were observed to be well
tolerated and consistently within safe limits and the safety
profiles of both AL001 and the marketed lithium carbonate capsule
were benign.
Such findings may allow the Company to reduce or eliminate the
need for Phase 2 and Phase 3 studies of efficacy and/or safety of
AL001 in such indications as bipolar/affective disorders in which
lithium efficacy has been established. Bioequivalence may have
utility for AL001 when seeking approval for the indications of
currently marketed lithium products, and for new indications as a
benchmark for safety. Given the systemic pharmacokinetic similarity
to marketed immediate-release lithium carbonate products, AL001 may
be dosed three times daily in the planned Phase 2 study, a multiple
ascending dose safety study in Alzheimer’s patients.
Mr. Jackman added, “We look forward to swiftly initiating a
Phase 2 multiple ascending dose study involving Alzheimer’s
patients in the second quarter of 2022. Additionally, we look
forward to pursuing investigational new drug applications with the
United States Food and Drug Administration during 2022 for bipolar
disorder, depression, and post-traumatic stress disorder
indication, and given the major unfilled public health need in
these indications, we intend to seek expedited regulatory
interaction.”
About AL001
AL001 is a patented ionic cocrystal technology delivering
lithium via a therapeutic crystal-engineered combination of
lithium, L-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
Alzamend Neuro is an early clinical-stage biopharmaceutical
company focused on developing novel products for the treatment of
neurodegenerative diseases and psychiatric disorders, including
Alzheimer’s. 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, 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. 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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