The Second Oral Therapy Approved This Decade,
ZUNVEYL’s Dual MOA Was Designed to Eliminate Drug Absorption in the
Gastrointestinal (GI) Tract, Potentially Addressing Certain
Tolerability Issues with Leading Alzheimer’s Disease (AD)
Medications, Combined with a Long-Term Efficacy Profile
ZUNVEYL’s Innovative Approach Targets AD
Symptoms Directly, Designed to Provide Patients with Significant
Benefits to Cognitive and Global Function and the Ability to
Perform Daily Living Activities
Alzheimer’s Disease, the Most Common Form of
Dementia, Affects Nearly 7 Million People in the United States,
including 70% of All Nursing Home Residents and is the Leading
Cause of Nursing Home Admissions and Deaths
Alpha Cognition (CSE: ACOG) (OTCQB: ACOGF) (Alpha
Cognition “ACI”, or the “Company”), a biopharmaceutical company
developing novel therapeutics for debilitating neurodegenerative
disorders, announces that the U.S. Food and Drug Administration
(FDA) has granted approval for ZUNVEYL® (benzgalantamine)
previously known as ALPHA-1062, for the treatment of
mild-to-moderate Alzheimer's disease. Alzheimer’s disease (AD) is a
progressive brain disorder that slowly destroys memory, thinking
skills, and eventually the ability to do simple tasks, like carry
on a conversation. AD is the most common form of dementia affecting
nearly 7 million people, and is the leading cause of nursing home
admissions and deaths, with 70% of all nursing home residents
suffering with AD.
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A novel oral therapy, ZUNVEYL has a dual mechanism of action
designed to eliminate drug absorption in the GI tract, potentially
addressing certain tolerability issues with leading AD medications,
combined with the efficacy and long-term benefit profile of
galantamine. Tolerability affects therapy adherence, with data
showing that 55% of AD patients discontinue their medication after
one year, mainly due to GI side effects and insomnia. Medication
discontinuation can cause risk to patients themselves, and
dissatisfaction and burden among nursing home staff, physicians,
and caregivers.
ZUNVEYL, a prodrug of AD treatment galantamine and an
acetylcholinesterase inhibitor (AChEI), is postulated to exert its
therapeutic effect by preventing the breakdown of acetylcholine,
the important brain neurotransmitter involved in memory,
motivation, and attention functions. It is also an allosteric
potentiator of α-7 nicotinic acetylcholine and α4β2 receptors. This
action facilitates the release of acetylcholine from the
presynaptic neurons, giving clinical significance to its dual mode
of action. ZUNVEYL targets AD symptoms, to provide patients with
long-lasting benefits to cognitive and global function and the
ability to perform daily activities that are impaired by AD.
Galantamine, FDA-approved since 2001, has extensive and positive
data related to long-term outcomes, demonstrating activity among
multiple brain receptors, anti-inflammatory effects, and is
associated with improved memory, attention, and a significantly
lower risk of death. It also has the strongest effect on cognitive
decline in the AChEI class of medications and demonstrated
significant risk reduction of developing severe dementia. Due to
its prodrug properties, ZUNVEYL is effectively converted into the
active moiety of galantamine after it passes through the GI tract,
therefore achieving the same therapeutic effects of galantamine. It
was also uniquely designed to eliminate drug absorption in the GI
tract, potentially addressing certain tolerability issues and has a
CNS safety profile that includes no incidence of insomnia.
Information about ZUNVEYL’s pivotal clinical studies are included
further in this press release, and in the ZUNVEYL prescribing
information.
“I am very excited about the approval of ZUNVEYL, which we
believe offers better tolerability for patients with Alzheimer's
disease. We have always believed in the efficacy of galantamine but
have been limited in its use due to tolerability issues. To now
have an agent with the efficacy of galantamine, but that also
offers the hope of better tolerability, will provide physicians a
great option to treat patients,” said Elaine Peskind, MD, the
Friends of Alzheimer’s Research Professor of Psychiatry at the
University of Washington School of Medicine. “This advancement
marks a meaningful step forward in improving the quality of life
for those living with Alzheimer's and their families. As a
geriatric psychiatrist specializing in Alzheimer’s disease, I am
eager to incorporate this new treatment into our practice and see
the positive difference it will make.”
“The approval of ZUNVEYL is a pivotal moment in the fight
against Alzheimer's disease as it is only the second oral AD
treatment to be approved in more than a decade. ZUNVEYL was
designed to addresses a critical need for a tolerable and effective
treatment that can potentially enhance patients' daily lives with
improved long-term outcomes,” stated Alpha Cognition Chief
Executive Officer Michael McFadden. “We are delighted, as this
represents a major breakthrough in Alzheimer's treatment, providing
hope to millions of patients, families, and caregivers affected by
this devastating disease.”
About the Pivotal ZUNVEYL Clinical
Studies
ZUNVEYL’s approval was based on chemistry, manufacturing, and
controls information and data demonstrating the bioequivalence and
tolerability of ZUNVEYL compared to galantamine immediate-release
tablets and galantamine extended-release capsules. Importantly,
there were minimal adverse events reported in these trials.
- Efficacy, Tolerability, Safety: The efficacy of ZUNVEYL
is based upon 3 bioavailability studies in healthy adults comparing
galantamine immediate-release tablets and galantamine
extended-release capsules to ZUNVEYL. GI adverse events documented
across all studies for ZUNVEYL were less than 2% and no insomnia
was observed.
- Dual Mechanism of Action: While precise mechanism of
action is not known, it is believed that ZUNVEYL works through two
distinct pathways to enhance neurotransmitter activity and protect
neuronal health, leading to improved cognitive and functional
outcomes.
- Long-Term Benefits: Clinical trials for galantamine
(ZUNVEYL’s active moiety) have demonstrated sustained improvements
in cognitive function and quality of life over extended periods of
treatment.
Availability
ZUNVEYL will be available by prescription in pharmacies
nationwide in Q1 2025. Alpha Cognition is committed to ensuring
broad access to this innovative treatment and will work closely
with healthcare providers, insurers, and patient advocacy groups to
support its distribution.
"We are excited to launch ZUNVEYL and bring this much-needed
treatment option to patients suffering from Alzheimer's disease,"
said Lauren D’Angelo, Alpha Cognition’s Chief Operating Officer.
"Over the coming months, our team will work diligently to prepare
for this launch, ensuring that healthcare providers have the
information and patients have the resources and support they need.
ZUNVEYL offers dual-action benefits with the established efficacy
of galantamine and no insomnia. It was uniquely designed to bypass
the gut with the potential of minimizing GI side effects. We
believe that ZUNVEYL’s unique combination of these attributes will
make a meaningful difference in the lives of those affected by this
debilitating disease. We look forward to collaborating with our
partners to ensure a successful rollout and broad
accessibility."
About Alpha Cognition Inc.
Alpha Cognition Inc. is a clinical stage, biopharmaceutical
company dedicated to developing treatments for patients suffering
from neurodegenerative diseases, such as Alzheimer’s disease and
Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for
which there are currently no approved treatment options.
ZUNVEYL, previously ALPHA-1062, is a novel patented oral
Alzheimer’s disease therapy with a dual mechanism of action
designed to eliminate drug absorption in the GI tract, potentially
addressing certain tolerability issues with leading AD medications,
combined with the efficacy and long-term benefit profile of
galantamine. As a new generation acetylcholinesterase inhibitor, it
was developed to demonstrate a potentially improved GI side effect
profile and has a CNS safety profile that includes no incidence of
insomnia. While precise mechanism of action is not known, it is
believed that ZUNVEYL works through two distinct pathways to
enhance neurotransmitter activity and protect neuronal health,
leading to improved cognitive and functional outcomes.
Separately, ZUNVEYL is also being developed in combination with
memantine to treat moderate-to-severe Alzheimer’s dementia, and as
an intranasal formulation for Cognitive Impairment with mTBI. For
more information about ZUNVEYL, please visit www.zunveyl.com or
contact info@alphacognition.com and connect with us on Twitter and
LinkedIn.
INDICATION
ZUNVEYL (benzgalantamine) is a cholinesterase inhibitor
indicated for the treatment of mild to moderate dementia of the
Alzheimer’s type in adults.
IMPORTANT SAFETY INFORMATION
INDICATION
ZUNVEYL® (benzgalantamine) is a cholinesterase inhibitor
indicated for the treatment of mild to moderate dementia of the
Alzheimer’s type in adults.
IMPORTANT SAFETY INFORMATION
Contraindications
ZUNVEYL is contraindicated in patients with known
hypersensitivity to benzgalantamine, galantamine, or any inactive
ingredients in ZUNVEYL.
Warnings and Precautions
- Serious Skin Reactions: Serious skin reactions
(Stevens-Johnson syndrome and acute generalized exanthematous
pustulosis) have been reported in patients receiving galantamine
(the active metabolite of (ZUNVEYL) tablets. If signs or symptoms
suggest a serious skin reaction, use of this drug should not be
resumed and alternative therapy should be considered.
- Cardiovascular conditions: Cholinesterase inhibitors,
including ZUNVEYL, may have vagotonic effects on the sinoatrial and
atrioventricular nodes. These effects may manifest as bradycardia
or heart block in patients both with and without known underlying
cardiac conduction abnormalities. Syncopal episodes have been
reported in association with the use of donepezil.
- Peptic ulcer disease and gastrointestinal bleeding:
Cholinesterase inhibitors, including ZUNVEYL, may increase gastric
acid secretion. Patients should be monitored closely for active or
occult gastrointestinal bleeding, especially those with a history
of ulcer disease or those receiving concurrent nonsteroidal
anti-inflammatory drugs (NSAIDs).
- Genitourinary conditions: Although not observed in
clinical trials of ZUNVEYL, bladder outflow obstruction may
occur.
- Pulmonary conditions: Cholinesterase inhibitors,
including ZUNVEYL, should be prescribed with care to patients with
a history of asthma or obstructive pulmonary disease. Monitor for
respiratory adverse effects.
Adverse Reactions
The most common adverse reactions with galantamine tablets (≥5%)
were nausea, vomiting, diarrhea, dizziness, headache, and decreased
appetite.
Drug Interactions
Cholinesterase inhibitors, including galantamine, have the
potential to interfere with the activity of anticholinergic
medications. A synergistic effect may be expected when
cholinesterase inhibitors are given concurrently with
succinylcholine, similar neuromuscular blocking agents, or
cholinergic agonists such as bethanechol.
These are not all of the possible side effects of ZUNVEYL. You
can report side effects to the FDA. Visit
www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click
here for Full Prescribing Information.
Forward-looking Statements
This news release includes forward-looking statements within the
meaning of applicable securities laws. Except for statements of
historical fact, any information contained in this news release may
be a forward‐looking statement that reflects the Company’s current
views about future events and are subject to known and unknown
risks, uncertainties, assumptions and other factors that may cause
the actual results, levels of activity, performance or achievements
to be materially different from the information expressed or
implied by these forward-looking statements. In some cases, you can
identify forward‐looking statements by the words “may,” “might,”
“will,” “could,” “would,” “should,” “expect,” “intend,” “plan,”
“objective,” “anticipate,” “believe,” “estimate,” “predict,”
“project,” “potential,” “target,” “seek,” “contemplate,” “continue”
and “ongoing,” or the negative of these terms, or other comparable
terminology intended to identify statements about the future.
Forward‐looking statements may include statements regarding the
ZUNVEYL efficacy and tolerability, ZUNVEYL long-term benefits, the
Company’s timing and planned activities to launch ZUNVEYL,
potential timing for the availability of ZUNVEYL, potential future
developments of ZUNVEYL, the potential market size for ZUNVEYL ,
the Company’s business strategy, market size, potential growth
opportunities, capital requirements, clinical development
activities, the timing and results of clinical trials, regulatory
submissions, potential regulatory approval and commercialization of
the Company’s products. Although the Company believes to have a
reasonable basis for each forward-looking statement, we caution you
that these statements are based on a combination of facts and
factors currently known by us and our expectations of the future,
about which we cannot be certain. The Company cannot assure that
the actual results will be consistent with these forward-looking
statements. These forward-looking statements are subject to certain
risks, including risks regarding our ability to raise sufficient
capital to implement our plans to commercialize ZUNVEYL , risks
regarding the efficacy and tolerability of ZUNVEYL , risks related
to ongoing regulatory oversight on the safety of ZUNVEYL, risk
related to market adoption of ZUNVEYL , risks related to the
Company’s intellectual property in relation to ZUNVEYL , risks
related to the commercial manufacturing, distribution, marketing
and sale of ZUNVEYL , risks related to product liability and other
risks as described in the Company’s filings with Canadian
securities regulatory authorities and available at www.sedar.com
and the Company’s filings with the United States Securities and
Exchange Commission (the “SEC”), including those risk factors under
the heading “Risk Factors” in the Company’s Form S-1 registration
statement as filed with the SEC on June 14, 2024 and available at
www.sec.gov. These forward‐looking statements speak only as of the
date of this news release and the Company undertakes no obligation
to revise or update any forward‐looking statements for any reason,
even if new information becomes available in the future, except as
required by law.
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For further information: Michael McFadden, CEO Tel:
1-858-344-4375 info@alphacognition.com