New Oral Alzheimer’s Drug ZUNVEYL Approved: Long-lasting Efficacy with Fewer Side Effects

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New Oral Alzheimer’s Drug ZUNVEYL Approved: Long-lasting Efficacy with Fewer Side Effects

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New Oral Alzheimer’s Drug ZUNVEYL Approved: Long-lasting Efficacy with Fewer Side Effects

July 29 – Alpha Cognition has announced that the FDA has approved Zunveyl (benzgalantamine, a cholinesterase inhibitor) for the treatment of mild to moderate Alzheimer’s disease (AD). This marks the second oral AD therapy approved in over a decade.

About Alzheimer’s Disease (AD)

Alzheimer’s disease (AD) is a progressive, irreversible neurodegenerative brain disorder that leads to cognitive impairment, psychiatric abnormalities, and loss of social and daily functioning. Epidemiological surveys indicate that among China’s population aged 60 and above, there are approximately 15.07 million dementia patients, with around 9.83 million having AD. Additionally, there are about 38.77 million individuals with mild cognitive impairment (MCI). AD has become the fifth leading cause of death in China, resulting in annual healthcare expenditures of up to $167.7 billion, placing a significant economic and social burden on the public health system.

One of the challenges in AD treatment is poor drug tolerance, which affects treatment adherence. Data shows that 55% of AD patients discontinue their medication within a year due to gastrointestinal side effects and insomnia. Discontinuation poses risks to patients and places a burden on caregivers, nursing home staff, and physicians. There is an urgent need for a medication that effectively alleviates symptoms while being well-tolerated by patients.

What is ZUNVEYL?

Zunveyl (formerly ALPHA-1062) is a prodrug of galantamine, featuring a dual mechanism of action. As an acetylcholinesterase inhibitor (AChEI), Zunveyl is believed to exert its therapeutic effect by preventing the breakdown of acetylcholine, a key neurotransmitter involved in memory, motivation, and attention. It also acts as an allosteric modulator of α-7 nicotinic acetylcholine and α4β2 receptors, enhancing the release of acetylcholine from presynaptic neurons.

Galantamine has been FDA-approved since 2001 and has shown broad, positive data related to long-term outcomes. It exhibits activity across various brain receptors, possesses anti-inflammatory properties, and is associated with improved memory, attention, and significantly reduced mortality risk. Among AChEIs, it has the most pronounced effect on slowing cognitive decline and reducing the risk of severe dementia.

Due to its prodrug nature, ZUNVEYL is effectively converted into the active component of galantamine after passing through the gastrointestinal tract, achieving the same therapeutic effects. As a newly patented oral AD therapy, Zunveyl is uniquely designed to block the interaction of the drug with acetylcholinesterase in the gastrointestinal nervous system. This reduces local neuronal overstimulation, decreases gastrointestinal side effects, and enhances bioavailability. This design addresses tolerance issues and provides central nervous system safety, including no incidence of insomnia.

Key Clinical Studies of ZUNVEYL

The approval of ZUNVEYL is based on chemistry, manufacturing, and control (CMC) data. These data demonstrated bioequivalence and tolerance compared to galantamine immediate-release tablets and extended-release capsules. Notably, few adverse events were reported in these trials.

• Efficacy, Tolerance, Safety: ZUNVEYL’s efficacy is based on three bioavailability studies in healthy adults, comparing galantamine immediate-release tablets and extended-release capsules with ZUNVEYL. Gastrointestinal adverse events recorded for ZUNVEYL in all studies were less than 2%, and no patients experienced insomnia.
• Dual Mechanism of Action: Although the exact mechanism of action is unclear, ZUNVEYL is believed to enhance neurotransmitter activity and protect neuronal health through two distinct pathways, improving cognitive and functional outcomes.
• Long-term Benefits: Clinical trials of galantamine (the active component of ZUNVEYL) indicate sustained improvement in cognitive function and quality of life during long-term treatment.
• Additionally, ZUNVEYL is being co-developed with memantine for the treatment of moderate to severe AD dementia and as an intranasal formulation for cognitive impairment caused by mTBI.

Alpha Cognition’s CEO, Michael McFadden, stated, “The approval of ZUNVEYL marks a pivotal moment in the fight against Alzheimer’s disease, as it is the second oral AD therapy approved in over a decade. ZUNVEYL aims to meet the urgent need for a well-tolerated and effective treatment, potentially improving patients’ daily lives and long-term outcomes.”

Conclusion

The complex etiology and multiple factors contributing to Alzheimer’s disease pose challenges to its drug development.

Despite this, ongoing exploration of new targets, multi-project collaborations, and identification of more suitable biomarkers by domestic and international pharmaceutical companies hold promise.

Currently, several AD candidate therapies with different mechanisms are in phase 2 and 3 clinical stages, offering hope for better treatment options for AD patients in the near future.

New Oral Alzheimer’s Drug ZUNVEYL Approved: Long-lasting Efficacy with Fewer Side Effects

(source:internet, reference only)

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