Pharma Focus Asia

Voyager Therapeutics Doses First Participants in VY-TAU01 Trial for Alzheimer’s Disease

Friday, May 17, 2024

Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotech company focused on neurogenetic medicines, announced the dosing of the first participants in its Phase 1a single ascending dose (SAD) trial of VY-TAU01. This investigational anti-tau antibody is being developed to prevent the spread of pathological tau in Alzheimer’s disease.

The SAD trial, which is randomized, double-blind, and placebo-controlled, aims to assess the safety and pharmacokinetics of VY-TAU01 in healthy adult volunteers. The study, taking place at a single U.S. site, plans to enroll around 48 participants in different cohorts. Findings from this trial will guide the design of a Phase 1b multiple ascending dose (MAD) trial in patients with early Alzheimer’s disease, expected to commence in 2025. The MAD study aims to produce initial tau PET imaging data by the second half of 2026, which could indicate whether VY-TAU01 can slow the spread of pathological tau in the brain.

Voyager Therapeutics' Chief Medical Officer, stated, "Initiating the clinical development of VY-TAU01 for Alzheimer’s disease is a significant achievement for Voyager. It underscores the capabilities of our neurology drug development team, which is crucial as we move forward with three neurology gene therapies toward IND filings next year. Despite recent advances, Alzheimer’s disease remains an area with substantial unmet needs. Our preclinical data, which shows VY-TAU01's potential to significantly slow tau spreading, is promising, and we look forward to evaluating its therapeutic potential in clinical settings."

VY-TAU01 is an intravenously administered, recombinant, humanized IgG4 monoclonal antibody designed to inhibit the spread of pathological tau, which is strongly associated with the progression and cognitive decline seen in Alzheimer’s disease. Unlike previous N-terminal directed anti-tau antibodies that failed to show efficacy in clinical trials, VY-TAU01 targets a unique C-terminal epitope of tau and has demonstrated robust inhibition of pathological tau spread in preclinical models. Additional studies have shown that VY-TAU01 is well-tolerated and has a favorable pharmacokinetic profile following IV administration.

Alzheimer’s disease is a progressive neurodegenerative disorder that affects approximately 6 million people in the U.S. and up to 416 million worldwide. It causes memory loss and can progress to reduced independence, communication difficulties, behavioral changes like paranoia and anxiety, and physical control issues. In 2023, the total cost of caring for individuals with Alzheimer’s and other dementias in the U.S. is estimated at $345 billion.



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