23 June 2022 - - Canada-based biopharmaceutical company Alpha Cognition Inc. (TSX Venture: ACOG) (OTCQB: ACOGF) has posted 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 Alzheimer's Disease, the company said.

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 2Q23.

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.

Alpha Cognition is a clinical stage, biopharmaceutical company focused on developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and Amyotrophic Lateral Sclerosis, 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.