FDA Approves Alpha Cognition's ZUNVEYL® for Alzheimer's Disease

Alpha Cognition, a biopharmaceutical company focused on neurodegenerative disorders, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for ZUNVEYL® (benzgalantamine), previously known as ALPHA-1062, for treating mild-to-moderate Alzheimer's disease. Alzheimer's is a progressive brain disorder that impairs memory, thinking skills, and the ability to perform simple tasks, affecting nearly 7 million people in the United States. It is the most common form of dementia and a leading cause of nursing home admissions and deaths.

ZUNVEYL, an innovative oral therapy, has been designed with a dual mechanism of action that eliminates drug absorption in the gastrointestinal (GI) tract, potentially addressing tolerability issues seen with other Alzheimer's disease (AD) medications. This dual mechanism enhances the efficacy and long-term benefits of galantamine, which is crucial given that 55% of AD patients discontinue their medication within a year due to side effects like GI issues and insomnia. Discontinuing medication not only poses risks to patients but also causes dissatisfaction among caregivers and healthcare staff.

ZUNVEYL is a prodrug of galantamine, an acetylcholinesterase inhibitor (AChEI), which prevents the breakdown of acetylcholine, a neurotransmitter vital for memory and attention. It also acts as an allosteric potentiator for certain nicotinic acetylcholine receptors, facilitating acetylcholine release from presynaptic neurons. This dual action is expected to provide long-lasting cognitive and global function benefits, helping patients perform daily activities better. Galantamine has been FDA-approved since 2001, showing extensive long-term positive outcomes, including improved memory, attention, and a reduced risk of severe dementia and death. ZUNVEYL converts effectively into galantamine after passing through the GI tract, achieving the same therapeutic effects without the GI absorption, thus minimizing potential side effects like insomnia.

Elaine Peskind, MD, a geriatric psychiatrist specializing in Alzheimer's disease, expressed enthusiasm over ZUNVEYL's approval, highlighting its potential to improve treatment tolerability while maintaining the efficacy of galantamine. She believes this development will significantly enhance the quality of life for Alzheimer's patients and their families.

Michael McFadden, CEO of Alpha Cognition, called the approval a pivotal moment in Alzheimer’s treatment, noting that ZUNVEYL is only the second oral AD treatment approved in over a decade. He emphasized the drug’s design to meet critical needs for effective and tolerable treatment, offering hope for better long-term outcomes for patients.

ZUNVEYL’s approval was based on data demonstrating bioequivalence and tolerability compared to other forms of galantamine, with minimal adverse events reported. The drug is expected to be available in pharmacies nationwide by Q1 2025. Alpha Cognition aims for broad access to this treatment, working closely with healthcare providers, insurers, and patient advocacy groups to support its distribution.

Lauren D’Angelo, Chief Operating Officer of Alpha Cognition, announced the company's commitment to ensuring that healthcare providers have the necessary information and resources for patients. She highlighted ZUNVEYL’s dual-action benefits and its design to bypass the gut, potentially minimizing GI side effects. D’Angelo believes ZUNVEYL will significantly impact those affected by Alzheimer’s disease, with the company prepared for a successful rollout.

Alpha Cognition Inc. continues to develop treatments for neurodegenerative diseases, such as Alzheimer's and Cognitive Impairment with mild Traumatic Brain Injury (mTBI). ZUNVEYL, with its dual mechanism, is also being developed in combination with memantine for moderate-to-severe Alzheimer's dementia and as an intranasal formulation for Cognitive Impairment with mTBI.