Alpha Cognition to Present ZUNVEYL® (Benzgalantamine) Clinical Data at 2025 Alzheimer's Association International Conference

Ottawa Citizen

28-04-2025

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VANCOUVER, British Columbia & DALLAS — Alpha Cognition Inc. (NASDAQ: ACOG) (the 'Company' or 'Alpha Cognition') today announced three upcoming presentations at the 2025 Alzheimer's Association International Conference (the 'AAIC'), taking place July 27–31, 2025 in Toronto, Canada.
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The presentations will highlight clinical studies supporting ZUNVEYL (benzgalantamine), the Company's lead product and a novel galantamine prodrug approved by the FDA in July 2024 and commercially launched in March 2025. The studies demonstrated bioequivalence to galantamine IR and ER and were integral to the NDA submission and approval.
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'We're excited to share data that underscore ZUNVEYL's potential to deliver meaningful clinical benefit to patients,' said Dr. Denis Kay, Chief Scientific Officer at Alpha Cognition. 'We believe ZUNVEYL offers an attractive new option for Alzheimer's disease patients and caregivers.'
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Presentation Schedule at AAIC 2025:
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Bioequivalence to Galantamine ER under Steady State Conditions
Poster #107147 | July 27, 2025
Bioequivalence to Galantamine IR under Fed and Fasting Conditions
Poster #107030 | July 28, 2025
Dose Proportionality Across 5–15 mg Range under Fasting Conditions
Poster #107255 | July 30, 2025
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About ZUNVEYL
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ZUNVEYL is a twice-daily treatment designed to address the cognitive symptoms of mild-to-moderate Alzheimer's disease. By enhancing cholinergic function in the brain, ZUNVEYL supports memory, learning, and overall cognitive function, offering a meaningful improvement for patients and their caregivers.
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Targeted for the long-term care market, ZUNVEYL is uniquely positioned to address the needs of a growing patient population in a segment valued at $2 billion annually in the United States. Alpha Cognition is committed to ensuring ZUNVEYL is accessible to patients and caregivers, supported by robust market access strategies and a dedicated commercial team.
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About Alpha Cognition Inc.
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Alpha Cognition Inc. is a commercial 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.
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Warnings and Precautions
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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.
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The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite.
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Drug Interactions
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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.
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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.
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Forward-Looking Statements
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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 presentation of ZUNVEYL at the 2025 Alzheimer's Association International Conference, the contraindications of ZUNVEYL, the warning and precautions of ZUNVEYL, the adverse reactions of ZUNVEYL, the clinical benefits of ZUNVEYL to patients, ZUNVEYL's efficacy and tolerability, ZUNVEYL's 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/A registration statement as filed with the SEC on January 10, 2025 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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