FDA Approves Alpha Cognition’s Zunveyl as Oral Therapy for Mild-to-Moderate Alzheimer Disease

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The FDA has approved Alpha Cognition’s Zunveyl (benzgalantamine), an oral therapy for treating mild-to-moderate Alzheimer disease (AD). According to the company, the approval marks a significant advancement in the treatment of AD by offering a novel approach with a dual mechanism of action designed to improve tolerability and efficacy. Zunveyl is a prodrug of galantamine, an acetylcholinesterase inhibitor (AChEI), that works by preventing the breakdown of acetylcholine, a crucial neurotransmitter involved in memory and attention. Alpha Cognition stated that Zunveyl functions as an allosteric potentiator, enhancing the release of acetylcholine from presynaptic neurons.¹

“I am very excited about the approval of Zunveyl, 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. 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,” said Elaine Peskind, MD, the Friends of Alzheimer’s Research Professor of Psychiatry, University of Washington School of Medicine, in a press release. “This advancement marks a meaningful step forward in improving the quality of life for those living with Alzheimer's and their families. As a geriatric psychiatrist specializing in Alzheimer’s disease, I am eager to incorporate this new treatment into our practice and see the positive difference it will make.”

The approval was based on positive results from the chemistry, manufacturing, and controls information and data demonstrating the bioequivalence and tolerability of Zunveyl from pivotal clinical studies comparing it to galantamine immediate-release tablets and galantamine extended-release capsules. According to the results of all three studies, gastrointestinal adverse events (AEs) were less than 2% and no insomnia was observed. Currently, investigators believe Zunveyl acts through two distinct pathways that enhance neurotransmitter activity and protect neuronal health, leading to improved cognitive and functional outcomes. The company stated that these clinical trials also demonstrated sustained improvements in cognitive function and quality of life over extended periods of treatment.

There were minimal AEs reported in the trial, the most common of which included nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Zunveyl is also associated with serious skin reactions, cardiovascular conditions, pulmonary conditions, genitourinary conditions, peptic ulcer disease, and gastrointestinal bleeding.¹

“The approval of Zunveyl is a pivotal moment in the fight against Alzheimer's disease as it is only the second oral AD treatment to be approved in more than a decade. 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,” stated Michael McFadden, CEO, Alpha Cognition, in the press release. “We are 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.”

Currently, an estimated 6.7 million people in the United States are living with AD and dementia, with experts projecting the number to grow to 13.8 million by 2060 unless there is a medical breakthrough aimed at preventing or curing the disease. AD is currently ranked as the seventh leading cause of death in the United States.²

"We are excited to launch Zenveyl and bring this much-needed treatment option to patients suffering from Alzheimer's disease," said Lauren D’Angelo, chief operating officer, Alpha Cognition, in the press release. "Over the coming months, our team will work diligently to prepare for this launch, ensuring that healthcare providers have the information, and patients have the resources and support they need. Zunveyl offers dual-action benefits with the established efficacy of galantamine and no insomnia. 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. We look forward to collaborating with our partners to ensure a successful rollout and broad accessibility."

References

1. Alpha Cognition’s Oral Therapy ZUNVEYL® Receives FDA Approval to Treat Alzheimer's Disease. BusinessWire. July 29, 2024. Accessed July 29, 2024. https://www.businesswire.com/news/home/20240729327804/en/Alpha-Cognition%E2%80%99s-Oral-Therapy-ZUNVEYL%C2%AE-Receives-FDA-Approval-to-Treat-Alzheimers-Disease

2. 2023 Alzheimer's disease facts and figures. Alzheimer’s Association. March 14, 2023. Accessed July 29, 2024. https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13016#:~:text=An%20estimated%206.7%20million%20Americans,Americans%20age%2065%20and%20older.