Alpha Cognition’s ALPHA-1062 Becomes the Second Oral FDA-Approved Treatment for Alzheimer’s Disease

The FDA approved Vancouver-based Alpha Cognition’s ALPHA-1062, also known as Zunveyl, for treating mild-to-moderate Alzheimer’s disease.

The approval came after results from four different studies demonstrated that the drug has the same bioequivalence as galantamine in its regular and extended-release forms. Zunveyl acts as a prodrug for the already-approved acetylcholinesterase inhibitor (AChEI).

Despite being considered a new-generation AChEI, Zunveyl surpasses galantamine in terms of tolerability and reported adverse events. Minimal gastrointestinal adverse events are expected with the treatment. According to the studies that led to the drug’s approval, only 2% of treated patients experienced adverse events. Additionally, no cases of insomnia were reported.

In the latter half of 2022, Alpha Cognition first revealed positive results from one of its bioequivalence studies for ALPHA-1062. In the study, 40 healthy volunteers were divided into two groups. One group received 8 mg capsules of galantamine hydrobromide daily, while the other received 5 mg pills of ALPHA-1062 twice a day. After a week-long washout period, the groups were crossed over and received the same dosage as the other group for the next week. Bioequivalence was demonstrated, and the area under the curve was achieved.

Due to tolerability issues, the efficacy of galantamine had been limited in the past. With better demonstrated tolerability, Zunveyl provides physicians with a better treatment option. Elaine Peskind, Professor of Psychiatry at the University of Washington School of Medicine, is one such geriatric psychiatrist specializing in Alzheimer’s disease who finds the prospect of this new treatment an exciting opportunity for practical use.

By maximizing the effectiveness of Zunveyl in treating Alzheimer’s disease and ensuring the drug has a robust safety profile, the hope is to expand the number of patients who can receive treatment and prolong the duration of treatment.

Michael McFadden, chief executive officer at Alpha Cognition, said in a statement, “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 address a critical need for a tolerable and effective treatment that can potentially enhance patients’ daily lives with improved long-term outcomes.”

Zunveyl is a delayed-release oral tablet formulation meant to be absorbed in the small intestine. In the gastrointestinal nervous system, the addition of a benzyl ester to galantamine blocks binding with AChE, reducing overstimulation in local neurons and increasing bioavailability. Its design allows it to bypass the gut, potentially minimizing adverse gastrointestinal events.

In the coming months, Alpha Cognition’s chief operating officer, Lauren D’Angelo, announced that the focus will be on providing healthcare providers and patients with the right information and resources and collaborating with caregivers to ensure accessibility and a steady rollout.

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