Alzamend Neuro Receives Positive Pre-IND Response from FDA for AL001 Treatment of Bipolar Disorder, Major Depressive Disorder and Post-Traumatic Stress Disorder
18 July 2022 - 10:00PM
Business Wire
- Topline data expected in December 2022 from Phase IIA
Multiple Ascending Dose Clinical Trial for AL001 Treatment of
Dementia Related to Alzheimer’s
- Full data from Phase I first-in-human study demonstrated
AL001 in plasma is bioequivalent to the marketed lithium carbonate
product
Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early
clinical-stage biopharmaceutical company focused on developing
novel products for the treatment of Alzheimer’s disease
(“Alzheimer’s”), bipolar disorder, major depressive disorder
(“MDD”) and post-traumatic stress disorder (“PTSD”), today
announced that it has received a written response to its meeting
request relating to its Type B Pre-Investigational New Drug (“IND”)
application from the U.S. Food and Drug Administration (the “FDA”).
The FDA’s response provides a path for Alzamend’s planned clinical
development of AL001 for the treatment of bipolar disorder, MDD and
PTSD. AL001 is a novel lithium-delivery system; specifically, it is
a lithium-salicylate-L-proline engineered ionic cocrystal under
development as an oral treatment for patients with dementia
resulting from mild, moderate or severe cognitive impairment caused
by Alzheimer’s. AL001 has the potential to deliver benefits of
marketed lithium carbonate while mitigating or avoiding current
toxicities associated with lithium.
Lithium was the first mood stabilizer and is still a first-line
treatment option, but is underutilized, perhaps because of the need
for therapeutic drug monitoring (“TDM”) to assure safe and
effective blood concentrations, and the availability of newer
treatments. Lithium is a commonly prescribed drug for manic
episodes in bipolar disorder as well as maintenance therapy of
bipolar disorder in patients with a history of manic episodes. The
primary target symptoms of bipolar disorder are mania and mood
swings. Lithium is also prescribed off-label for MDD (often as an
adjunct therapy), bipolar disorder (without a history of mania),
and treatment of PTSD, among other neurodegenerative, neurological
and neuropsychiatric disorders.
Lithium was the first drug that required TDM by regulatory
authorities in product labelling because the effective and safe
range of therapeutic drug blood concentrations is narrow and well
defined for treatment of bipolar disorder when using lithium salts.
Excursions above this range can be toxic. AL001 may enhance lithium
distribution into target tissues in the central nervous system
(brain) but at lower systemic exposures, resulting in an improved
safety profile compared to lithium salts, including the possibility
of mitigating lithium side effects and the current requirement for
TDM.
In a Phase I relative bioavailability comparison of AL001 to
lithium carbonate completed in March 2022, AL001 was shown to
provide dose-normalized bioequivalent plasma pharmacokinetics and
the observed safety profile was benign. A phase IIA, Multiple
Ascending Dose (“MAD”) clinical trial for the treatment of dementia
related to Alzheimer’s is currently underway. Alzamend plans to
conduct further studies designed to enable it to ascertain
comparative brain penetration and persistence of AL001 to lithium
carbonate. These studies are expected to help predict observations
seen in pharmacokinetic nonclinical findings to improve treatments
in humans, including the potential for AL001 to exhibit lithium
dose sparing properties that could mitigate lithium side effects
and the current requirement for TDM in blood. Lithium was the first
drug that required TDM by regulatory authorities in product
labelling because the effective and safe range of therapeutic drug
blood concentrations is narrow and well defined for treatment of
bipolar disorder when using lithium salts. Excursions above this
range can be toxic. Since providing a greater concentration of
lithium to the brain while minimizing the amount of the drug
delivered to other organs can improve overall safety, AL001 has the
potential to provide a safer product compared to currently marketed
lithium salts.
“We appreciate the thorough and meaningful response from the
FDA, which provides us with the information and clarity needed to
submit IND applications to initiate clinical trials for AL001 for
the treatment of bipolar disorder, MDD and PTSD,” said Stephan
Jackman, Chief Executive Officer of Alzamend. “We are one step
closer to substantiating that AL001 can 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, bipolar disorder, MDD, and
PTSD. We appreciate the FDA’s recommendations, guidance, and other
helpful advice. We plan to enhance our proposed clinical trial
protocols and proceed accordingly.”
Based on the FDA’s written feedback, Alzamend anticipates filing
the INDs for bipolar disorder, MDD and PTSD upon the completion of
the current Phase IIA MAD study. This will allow Alzamend to
initiate Phase II clinical trials for all three new
indications.
About AL001 Phase IIA Study
The ongoing Phase IIA study is evaluating the safety and
tolerability of AL001 under multiple-dose, steady‑state conditions
and is determining the maximum tolerated dose in patients diagnosed
with mild to moderate Alzheimer’s. Lithium has been well
characterized for safety and is approved/marketed in multiple
formulations for bipolar disorder. Lithium dosing for the MAD
cohorts consists of fractions of a usual dose for treatment of
bipolar disorder. In each cohort, consisting of six active and two
placebo patients (as per randomization), multiple ascending doses
are being administered three times daily for 14 days under fasted
conditions (at least one hour before or four hours after meals) up
to tolerability/safety limits for this fragile Alzheimer’s
population. The lithium and salicylate components of AL001 are to
be given within the amounts already approved for use in patients
for other indications. Up to 40 subjects will complete the Phase
IIA trial. The maximum tolerated dose will then be used for further
studies. The Phase IIA study commenced on May 5, 2022. More
information can be found at www.clinicaltrials.gov, identifier:
NCT05363293.
About AL001 Phase I Study
During this Phase 1 trial, participants received a single dose
of AL001 containing lithium in an amount equivalent to 150 mg
lithium carbonate, a dose proposed as likely appropriate for
Alzheimer’s treatment when given three times daily. Currently,
marketed lithium carbonate 300 mg capsules are often given three
times daily when prescribed for manic episodes in bipolar disorder
as well as for maintenance therapy of bipolar disorder in patients
with a history of manic episodes. It can be difficult to control
the appropriate dose of lithium salt formulations, including
lithium carbonate, due to the small margin between effective and
toxic blood levels, and therefore it can be challenging to avoid
side effects or inadequate treatment outcomes.
Dose-adjusted relative bioavailability analyses of the rate and
extent of lithium absorption in plasma indicated that AL001 at 150
mg lithium carbonate equivalent dosage is bioequivalent when
dose-normalized to the marketed 300 mg lithium carbonate product
and the shapes of the lithium plasma concentration versus time
curves are highly similar. Based on the Phase I study results, it
has been shown that dose-normalized systemic bioequivalence for
lithium was established between AL001 and the marketed reference
lithium carbonate 300 mg capsule. Findings of plasma bioequivalence
to a marketed lithium product may allow Alzamend to design a
development program that will potentially reduce the amount of new
data generated to support approval. Demonstrated systemic
bioequivalence also may have utility for AL001 when seeking
approval for new indications as a benchmark for safety.
About Alzamend Neuro
Alzamend is an early clinical-stage biopharmaceutical company
focused on developing novel products for the treatment of
Alzheimer’s, bipolar disorder, 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, 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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