Latest news with #DenisKay
Business Wire
01-07-2025
- Health
- Business Wire
Alpha Cognition Announces Positive Pre-Clinical Data for ALPHA-1062 Use in a Military Relevant Model of Repetitive Mild Traumatic Brain Injury
VANCOUVER, British Columbia & DALLAS--(BUSINESS WIRE)--Alpha Cognition Inc. (Nasdaq: ACOG) ('Alpha Cognition' [ACI], or the 'Company'), a biopharmaceutical company developing novel therapies for debilitating neurodegenerative disorders, today announced preclinical data supporting the continued development of ALPHA-1062 for the treatment of mild traumatic brain injury (mTBI). The data provides additional evidence of benefits of ALPHA-1062, in the treatment of mTBI resulting from repetitive blast trauma, a highly relevant military injury. Service related mTBI results in a high incidence of persistent physical and emotional challenges for patients, impacting their quality of life and that of their families. Additionally, a history of mTBI increases the risk of dementia diagnosis later in life. Data analysis for this study, supported by the US Department of Defense and conducted in collaboration with US Department of Veterans Affairs investigators and the Seattle Institute of Biomedical and Clinical Research, has been concluded, demonstrating that ALPHA-1062 administration following blast induced mTBI, results in a notable reduction in indices of TBI associated neuropathology. ALPHA-1062 administration reduced the brain levels of three toxic forms of a brain protein Tau. One of these forms (pTau 217) has been suggested to identify TBI patients at greater risk of long-term cognitive decline. It is also one of the earliest emerging biomarkers in Alzheimer's disease. A second form of toxic Tau (pTau-S202/T205) can be found in very early-stage pathology in the brains of Alzheimer's patients before the appearance plaques and tangles. The third form (pTau 231) is elevated in early Alzheimer's disease and TBI. Taken together, reduction of these toxic forms of pTau suggests a potential role for ALPHA-1062 in the treatment of TBI and that this may additionally positively impact the risk of later developing Alzheimer's disease. Additional benefits of ALPHA-1062 were observed following blast trauma. High dose ALPHA-1062 reduced the numbers of myeloid cells which play a critical role in neuroinflammation and tissue repair, as well as the number of astrocytes, which regulate neurotransmitters like glutamate and GABA to support neuronal health. These changes are consistent with reduced neuroinflammation following ALPHA-1062 administration. Finally, nerve growth factor receptor expression, which plays an important role in neuronal survival, was increased in an ALPHA-1062 dose-dependent manner. 'These outcomes are in agreement with those of an earlier pre-clinical study in a moderate TBI animal model, both studies demonstrated protective effects of ALPHA-1062, providing support for the continued development of ALPHA-1062 for the treatment of traumatic brain injury,' said Denis Kay, ACI's Chief Scientific Officer. Alpha Cognition's next steps in this program will be to complete formulation of ALPHA-1062 for sublingual administration and conduct a bridging pharmacokinetic study vs. ZUNVEYL® (Benzgalantamine) and an existing intranasal formulation of ALPHA-1062. About Alpha Cognition Inc. 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. ALPHA-1062 formulated as a delayed release oral tablet ZUNVEYL (Benzgalantamine) is FDA approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ZUNVEYL's active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia, and as a sublingual formulation for cognitive Impairment with mTBI. 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 potential benefits of the licensing agreement for the development and commercialization of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand, the Company's timing and planned activities to launch ZUNVEYL in the U.S. and China, the timing for the Company's planned corporate update call, the potential timing for the availability of ZUNVEYL in the U.S. and China, the potential future developments of ZUNVEYL in China, the potential market size for ZUNVEYL in China, the Company's business strategy for the launch of ZUNVEYL in China, the market size and demand for ZUNVEYL in China, the Company's potential growth opportunities in China, the timing and results of the Company's milestone payments for China, the Company's regulatory submissions in China, and the potential regulatory approval and commercialization of the Company's products in China. 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 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 November 6, 2024 and available at 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.
National Post
28-04-2025
- Health
- National Post
Alpha Cognition to Present ZUNVEYL® (Benzgalantamine) Clinical Data at 2025 Alzheimer's Association International Conference
Article content 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. Article content Article content 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. Article content '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.' Article content Presentation Schedule at AAIC 2025: Article content 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 Article content About ZUNVEYL Article content 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. Article content 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. Article content About Alpha Cognition Inc. Article content 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. Article content Contraindications Article content ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or any inactive ingredients in ZUNVEYL. Article content Warnings and Precautions Article content 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. Article content Article content Adverse Reactions Article content The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Article content Drug Interactions Article content 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. Article content These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Article content 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 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 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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Ottawa Citizen
28-04-2025
- Health
- Ottawa Citizen
Alpha Cognition to Present ZUNVEYL® (Benzgalantamine) Clinical Data at 2025 Alzheimer's Association International Conference
Article content 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. Article content Article content 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. Article content Article content '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.' Article content Presentation Schedule at AAIC 2025: Article content 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 Article content About ZUNVEYL Article content 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. Article content 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. Article content About Alpha Cognition Inc. Article content 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. Article content Warnings and Precautions Article content 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. Article content The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Article content Drug Interactions Article content 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. Article content These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Article content Forward-Looking Statements Article content 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 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 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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