Alpha Cognition Announces Positive Results from Pivotal Study with ALPHA-1062 in Development for Alzheimer’s Disease – Business Wire

VANCOUVER, British Columbia--(BUSINESS WIRE)--Alpha Cognition Inc. (TSX-V: ACOG) (OTCQB: ACOGF) (Alpha Cognition, or the Company), a biopharmaceutical company committed to developing novel therapies for people with debilitating neurodegenerative disorders, today announced positive results from its pivotal bioequivalence study with ALPHA-1062, a proprietary, delayed release oral tablet formulation in development for the treatment of mild to moderate Alzheimers Disease (AD).

The study was designed to demonstrate pharmacokinetic equivalence compared to the reference listed drug galantamine hydrobromide, which is a standard of care treatment for patients with mild to moderate AD. Topline results confirmed in fed and fasted bioequivalence studies that ALPHA-1062 achieved bioequivalent area-under-the-curve and peak exposures relative to galantamine hydrobromide IR. Data were within the required pharmacokinetic range of prior data demonstrated with galantamine hydrobromide ER. There were no adverse events reported for ALPHA-1062 during these studies. With these positive pivotal study results, Alpha Cognition plans to file an NDA for ALPHA-1062 in mild to moderate AD in Q2 2023.

Cedric OGorman, MD, Chief Medical Officer of Alpha Cognition, commented, We are very pleased with the positive results from the current studies of our lead asset, ALPHA-1062. If approved, ALPHA-1062 could provide a meaningful advancement for patients with Alzheimers Disease, especially those who are unable to tolerate the gastrointestinal side effects that often occur with many of the current treatment options.

ALPHA-1062, a patented new oral therapy, is a delayed release pro-drug of galantamine, uniquely designed to reduce GI adverse effects by remaining inert as it passes through the stomach. Currently approved drugs for AD are associated with significant adverse events, including nausea, vomiting, diarrhea, and insomnia. As a result, it is unpleasant and impractical for many patients to utilize these drugs for extended periods of time, resulting in a significant unmet need for effective and tolerable treatments for AD.

There is a significant need for innovative new treatment options for patients living with Alzheimers Disease, as the currently available medicines offer limited symptomatic relief, said Dr. James Galvin, MD, Professor of Neurology, Chief of the Division of Cognitive Neurology, and Director of the Comprehensive Center for Brain Health at the University of Miami. If approved by the FDA, ALPHA-1062 could provide an exciting next-generation treatment option for patients living with Alzheimers Disease.

The Alpha Cognition management team will hold a conference call to discuss the Companys top line results and outlook at 8:00 a.m. ET, Wednesday (today), June 22, 2022. The call will be open to the public.

Webcast Link: https://event.webcasts.com/starthere.jsp?ei=1556554&tp_key=77b62298d2

Participant Dial-In: 877-497-9067 / +1 201-493-6706

For more details on the above topic please join us on the conference call or refer to our Corporate Presentation on our website at: https://www.alphacognition.com/investors/presentations/

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 Amyotrophic Lateral Sclerosis (ALS), for which there are limited 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 traumatic brain injury.

ALPHA-0602 (Progranulin) is expressed in several cell types in the central nervous system and in peripheral tissues, promotes cell survival, regulates certain inflammatory processes, and plays a significant role in regulating lysosomal function and microglial responses to disease. Its intended use for the treatment of neurodegenerative diseases has been patented by the Company and Alpha-0602 has been granted an Orphan Drug Designation for the treatment of ALS by the FDA. ALPHA-0702 and ALPHA-0802 are Granulin Epithelin Motifs, or GEMs, derived from full length progranulin which have therapeutic potential across multiple neurodegenerative diseases. GEMs have been shown to be important in regulating cell growth, survival, repair, and inflammation. Alpha-0702 and ALPHA-0802 are designed to deliver this with potentially lower toxicity, and greater therapeutic effect.

Neither TSX Venture Exchange (the TSX-V), OTC Markets Group, nor the TSX-Vs 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 forwardlooking statement that reflects the Companys 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. Forwardlooking 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. Forwardlooking statements in this news release include statements regarding the Companys 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 Companys 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 Companys 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 forwardlooking 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 forwardlooking 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.

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Alpha Cognition Announces Positive Results from Pivotal Study with ALPHA-1062 in Development for Alzheimer's Disease - Business Wire