Alpha Cognition Announces Positive Pre-Clinical Data for ALPHA-1062 Use in a Military Relevant Model of Repetitive Mild Traumatic Brain Injury
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 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 November 6, 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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