Vancouver-based Alpha Cognition, a biopharmaceutical company with a North Texas office in Frisco, said the U.S. Food and Drug Administration has granted approval for its  ZUNVEYL oral therapy to treat Alzheimer’s disease.

Alpha Cognition develops novel therapeutics for debilitating neurodegenerative disorders. The company said that ZUNVEYL, previously known as ALPHA-1062, is used for the treatment of mild-to-moderate Alzheimer’s disease (AD). Dallas Innovates wrote about about the drug’s progress at the FDA in December.

Michael McFadden

“The approval of ZUNVEYL is a pivotal moment in the fight against Alzheimer’s disease as it’s only the second oral AD treatment to be approved in more than a decade,” Alpha Cognition CEO Michael McFadden said in a statement. “ZUNVEYL was designed to addresses a critical need for a tolerable and effective treatment that can potentially enhance patients’ daily lives with improved long-term outcomes.”

“We’re delighted, as this represents a major breakthrough in Alzheimer’s treatment, providing hope to millions of patients, families, and caregivers affected by this devastating disease,” McFadden added.

Alpha Cognition was honored at the 2023 BioNTX iC3 Summit as one of eight “Rising Stars.”

Elaine Peskind, MD, the Friends of Alzheimer’s Research Professor of Psychiatry at the University of Washington School of Medicine, said she’s excited about the drug’s approval, “which we believe offers better tolerability for patients with Alzheimer’s disease.”

“We have always believed in the efficacy of galantamine but have been limited in its use due to tolerability issues,” Peskind added in a statement. “To now have an agent with the efficacy of galantamine, but that also offers the hope of better tolerability, will provide physicians a great option to treat patients,” 

Impact of tolerability challenges

Alzheimer’s disease is a progressive brain disorder that slowly destroys memory, thinking skills, and eventually the ability to do simple tasks, like carry on a conversation, the company noted. It’s the most common form of dementia affecting nearly 7 million people and is the leading cause of nursing home admissions and deaths, with 70% of all nursing home residents suffering from AD, the company said.

Alpha Cognition said that ZUNVEYL has a dual mechanism of action designed to eliminate drug absorption in the GI tract, potentially addressing certain tolerability issues with leading AD medications, combined with the efficacy and long-term benefit profile of galantamine.

The company said that tolerability affects therapy adherence.

Data shows that 55% of AD patients discontinue their medication after one year, mainly due to GI side effects and insomnia. Medication discontinuation can cause risk to patients themselves, and dissatisfaction and burden among nursing home staff, physicians, and caregivers.

“This advancement marks a meaningful step forward in improving the quality of life for those living with Alzheimer’s and their families,” Peskind said. “As a geriatric psychiatrist specializing in Alzheimer’s disease, I’m eager to incorporate this new treatment into our practice and see the positive difference it will make.”

ZUNVEYL, a prodrug of AD treatment galantamine and an acetylcholinesterase inhibitor (AChEI), is postulated to exert its therapeutic effect by preventing the breakdown of acetylcholine, the important brain neurotransmitter involved in memory, motivation, and attention functions, according to the company.

It is also an allosteric potentiator of α-7 nicotinic acetylcholine and α4β2 receptors.

The company said this action facilitates the release of acetylcholine from the presynaptic neurons, giving clinical significance to its dual mode of action.

Making ‘a meaningful difference’ for those with AD

According to Alpha Cognition, ZUNVEYL targets Alzheimer’s symptoms, providing patients with “long-lasting benefits” to cognitive and global function and the ability to perform daily activities that are impaired by AD.

Lauren D’Angelo, Alpha Cognition’s chief operating officer, said that she and her team are excited to bring the new treatment to AD patients and that they would work diligently to make sure that healthcare providers and patients have the information, resources, and support they need with the launch of ZUNVEYL. 

“ZUNVEYL offers dual-action benefits with the established efficacy of galantamine and no insomnia,” D’Angelo said. “It was uniquely designed to bypass the gut with the potential of minimizing GI side effects. We believe that ZUNVEYL’s unique combination of these attributes will make a meaningful difference in the lives of those affected by this debilitating disease.

The goal is to positively impact those with Alzheimer’s disease.

D’Angelo said, “We look forward to collaborating with our partners to ensure a successful rollout and broad accessibility.”

Founded in 2000, Alpha Cognition 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, for which there are currently no approved treatment options.

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