Alpha Cognition Announces the Acceptance of its US FDA Investigational New Drug Application (IND) for Lead Candidate, ALPHA-1062 for Mild to Moderate Alzheimer’s Disease

By: Alpha Cognition Inc. via Business Wire

September 07, 2021 at 09:00 AM EDT

Alpha Cognition Inc. (TSX-V: ACOG)(OTCQB:ACOGF)(“Alpha Cognition”, or the “Company”), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating neurodegenerative disorders, is pleased to announce the U.S. Food and Drug Administration (“FDA”) has accepted its Investigational New Drug (IND) application for lead candidate, ALPHA-1062, to proceed with the pivotal clinical phase (the “Pivotal”) of the development program. The Company plans to initiate a Pivotal relative bioavailability study of ALPHA-1062, a proprietary, delayed release oral tablet formulation designed to treat mild to moderate Alzheimer’s Disease. This single set of trials, if successful, will allow the company to submit a New Drug Application (“NDA”) for ALPHA-1062 in 2022. ALPHA-1062 is being developed as a new generation of acetylcholine esterase inhibitor (AChEI) designed to improve upon the existing standard of care by overcoming gastrointestinal side effects and tolerability limitations.

“This first IND for Alpha Cognition represents a significant milestone for the Company as we transition to a clinical-stage organization,” said Dr. Frederick Sancilio, President and Head of Clinical Development, of Alpha Cognition. “It is well known that acetylcholine esterase inhibitors hold significant clinical potential; however, treatment with these therapies has been limited because of challenging GI tolerability issues. We have engineered ALPHA-1062 with the goal of enhancing the desirable features of an AChEI while limiting the known liabilities.”

Site initiation activities are underway for the study. The Company anticipates that enrollment will commence Q3 2021. If the results of the pivotal studies are successful, the Company expects to submit a 505(b)(2) New Drug Application as early as Q3 2022.

The clinical studies being deployed are designed to assess the equivalence of pharmaceutical products based on their pharmacokinetic profiles as compared to an existing and approved drug. They are generally performed in healthy subjects. These studies are relatively short in duration and provide a development path that is substantially less costly and more streamlined than typical clinical development programs, which require studies demonstrating safety and efficacy. The metabolite of Alpha-1062 is an approved drug (galantamine) to treat Alzheimer’s disease, and therefore qualifies for this shortened approval pathway.

A Section 505(b)(2) NDA is an NDA in which the applicant may rely on certain investigations of safety and effectiveness that were previously conducted by someone other than the applicant, and typically relates to an active drug substance that has previously been approved in a different form.

Neither TSX Venture Exchange (the “TSX-V”), OTC Markets Group, nor the TSX-V’s Regulation Services Provider (as that term is defined in policies of the TSX-V) accepts responsibility for the adequacy or accuracy of this release.

Forward-looking Statements

This news release is not, and under no circumstances is to be construed as, an advertisement or a public offering of securities. No securities commission or similar authority in Canada or in any other jurisdiction has reviewed or in any way passed upon this news release or the merits of the securities described herein and any representation to the contrary is an offence.

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. Forward‐looking statements can be identified 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 in this news release include statements regarding 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 technology. Although the Company believes that we 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 as a result of known and unknown risks, uncertainties, assumptions and other factors. These risks, uncertainties, assumptions and other factors include those associated with clinical studies and manufacturing, as well as development and commercialization of the Company’s products; the need for additional financing to maintain operations; risks posed by the economic and political environments in which the Company operates and intends to operate; market instability due to the COVID-19 pandemic; the potential for losses arising from the expansion of operations into new markets; increased competition; assumptions regarding market trends and the expected demand and desires for the Company’s products and proposed products; reliance on industry manufacturers, suppliers and key personnel; the failure to adequately protect intellectual property; a failure to adequately manage future growth; adverse market conditions; and failure to satisfy ongoing regulatory requirements or obtain regulatory approvals. These forward‐looking statements speak only as of the date of this news release and, other than as required by applicable securities laws, the Company undertakes no obligation to revise or update any forward‐looking statements, even if new information becomes available in the future.

This news release may also contain estimates and other statistical, market and industry data from independent parties or made by the Company relating to our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. We cannot guarantee the accuracy and completeness of information from third party sources.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210907005192/en/

Contacts

Bristol Investor Relations

Stefan Eftychiou

905 326 1888 ext 6

stefan@bristolir.com

https://www.alphacognition.com/

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Alpha Cognition Announces the Acceptance of its US FDA Investigational New Drug Application (IND) for Lead Candidate, ALPHA-1062 for Mild to Moderate Alzheimer’s Disease

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