Voyager Therapeutics Doses First Participants in Alzheimer’s Disease Trial

Voyager Therapeutics (Nasdaq: VYGR) has dosed the first participants in its Phase 1a trial of VY-TAU01, an investigational anti-tau antibody developed to inhibit the spread of pathological tau in Alzheimer’s disease. The 48-patient, single site study will evaluate the safety and pharmacokinetics of VY-TAU01 in healthy adult volunteers. Voyager believes that VY-TAU01 has the potential to slow the spread of pathological tau in the brain. Tau protein tangles can cause cell damage and inflammation, contributing to Alzheimer’s disease symptoms.

The results of Voyager’s randomized, double-blind, placebo-controlled study will inform the design of a Phase 1b multiple ascending dose (MAD) trial in patients with early Alzheimer’s disease, which the company says it expects to initiate in 2025.

Commenting on the update, Toby Ferguson, M.D., Ph.D., Chief Medical Officer of Voyager Therapeutics, said, “The initiation of clinical development of VY-TAU01 for the treatment of Alzheimer’s disease is an important milestone for Voyager; it demonstrates the executional abilities of our neurology drug development team, which will be central to our advancement of three wholly-owned and partnered neurology gene therapies towards IND filings next year. Alzheimer’s disease remains an area with tremendous unmet patient need, despite recent advances. We are encouraged by our preclinical data demonstrating the ability of VY-TAU01 to significantly slow tau spreading, and we look forward to evaluating the therapeutic potential of VY-TAU01 in the clinic.”

The MAD study has the potential to generate initial data in the second half of 2026, which may indicate if VY-TAU01 can slow the spread of pathological tau in the brain.

About Voyager Therapeutics

Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. Our pipeline includes programs for Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc.; and Sangamo Therapeutics, Inc. For more information, visit www.voyagertherapeutics.com.

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Voyager Therapeutics Doses First Participants in Alzheimer’s Disease Trial

Catie Corcoran

Biotech Editor