Full Press Release Details
Cognition's Oral Therapy ZUNVEYL Receives FDA Approval to Treat Alzheimer's Disease
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
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
Disease, the Most Common Form of Dementia, Affects Nearly 7million People in the United States, including 70% of All Nursing Home Residents
and is the Leading Cause of Nursing Home Admissions and Deaths
B.C., and Dallas, July 29, 2024 - 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.
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.
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 -7 nicotinic acetylcholine
and 4 2 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.
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."
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."
the Pivotal ZUNVEYL Clinical Studies
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.
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.
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."
Alpha Cognition Inc.
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.
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.
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.
(benzgalantamine) is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type
(benzgalantamine) is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type
is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or any inactive ingredients in ZUNVEYL.
most common adverse reactions with galantamine tablets ( 5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite.
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.
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.
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