Alpha Cognition Announces FDA Acceptance of New Drug Application for ALPHA-1062 for Mild-to-Moderate Alzheimer’s Disease

VANCOUVER, British Columbia--(BUSINESS WIRE)--Alpha Cognition Inc. (CSE: ACOG) (OTCQB: ACOGF) (Alpha Cognition “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, is pleased to announce that the U.S. Food and Drug Administration (FDA) has completed its filing review and has accepted the company’s New Drug Application (NDA) for ALPHA-1062, a proprietary, patented, delayed release oral tablet formulation in development for the treatment of mild-to-moderate Alzheimer’s Disease. The NDA has been granted a Prescription Drug User Fee Act (PDUFA) goal date of July 27th, 2024.

The NDA submission is based on results from four studies the Company conducted demonstrating bioequivalence for ALPHA-1062 to galantamine and galantamine ER. Adverse events documented across all studies for ALPHA-1062 were less than 2% and no insomnia was observed.

“The FDA’s acceptance of our NDA for ALPHA-1062 brings us another significant step closer to delivering a much-needed treatment to patients suffering from Alzheimer’s Disease,” said Michael McFadden, Chief Executive Officer of Alpha Cognition. “We look forward to continuing our collaboration with the FDA throughout the review process.”

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.

ALPHA-1062, is a patented new chemical entity being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ALPHA-1062’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 an intranasal formulation for Cognitive Impairment with mTBI.

Forward-looking Statements

Certain information contained herein constitutes “forward-looking information” under Canadian securities legislation. Forward-looking information includes, but is not limited to, statements with respect to Frontier’s services and term of engagement. Generally, forward-looking information can be identified by the use of forward-looking terminology such as “will” or variations of such words and phrases or statements that certain actions, events or results “will” occur. Such forward looking statements include statements regarding the potential benefits of ALPHA-1062 and the timeline to receiving FDA acceptance of the NDA. Such statements, and other forward-looking statements herein, are based on the opinions and estimates of management as of the date such statements are made and they are subject to known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from those expressed or implied by such forward-looking statements or forward-looking information. Although management of the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.