Voyager Announces Positive Results for Anti-Tau Antibody Trial and Begins New Alzheimer’s Study

Voyager Therapeutics, Inc., a biotechnology company based in Lexington, Massachusetts, has announced promising results from its single ascending dose (SAD) trial of VY7523. This investigational anti-tau antibody is designed to selectively inhibit the spread of pathological tau in Alzheimer's disease (AD). The trial results indicated that VY7523, when administered intravenously, was safe, well-tolerated, and exhibited dose-proportional pharmacokinetics. Following this success, Voyager has commenced a multiple ascending dose (MAD) study involving patients with early-stage Alzheimer's disease, with initial imaging data anticipated in the latter half of 2026.

Dr. Toby Ferguson, Chief Medical Officer of Voyager Therapeutics, expressed enthusiasm about targeting tau in Alzheimer's treatment, highlighting the potential of VY7523 to be a leading candidate based on its pharmacokinetic profile and preclinical data. These data showed a significant reduction in tau spread by 70% and specificity for a unique C-terminal epitope of pathological tau. The company is optimistic about forthcoming third-party data, which may generate further interest in tau-targeted therapies.

The SAD trial was a randomized, double-blind, placebo-controlled study conducted on 48 healthy volunteers. It aimed to evaluate the safety, tolerability, and pharmacokinetics of VY7523 in single IV doses. The trial met its primary objective with no serious adverse events or infusion reactions reported. Secondary objectives were also achieved, with serum concentrations of VY7523 increasing proportionally with dosage and the cerebrospinal fluid-to-serum ratio aligning with other approved monoclonal antibodies for Alzheimer's treatment. Voyager plans to present more detailed findings from the SAD trial at a future scientific conference.

The ongoing MAD study involves 52 patients with early Alzheimer's, specifically those with mild cognitive impairment or mild AD. The study is structured as a randomized, double-blind, placebo-controlled trial, focusing on the primary endpoint of safety and tolerability. Key secondary endpoints include the drug's ability to prevent the spread of pathological tau, assessed through tau PET imaging. Other secondary endpoints involve immunogenicity and pharmacokinetic parameters. Initial tau PET imaging data from this study are expected by the end of 2026.

VY7523 is a recombinant, humanized IgG4 monoclonal antibody administered intravenously, developed to inhibit the spread of pathological tau—a factor closely linked with disease progression and cognitive decline in Alzheimer's patients. The antibody targets a specific C-terminal epitope of tau, which is distinct in its preferential binding to pathological tau forms. Preclinical studies demonstrated that the murine version of VY7523 successfully reduced tau spread by approximately 70%.

Alzheimer's disease is a progressive neurodegenerative disorder that affects millions of people worldwide, including an estimated 7 million in the United States. The disease typically begins with memory loss and can progress to severe cognitive impairment, behavioral issues, and physical decline. In 2023, the cost of care for individuals with Alzheimer's and other dementias in the U.S. was estimated at $345 billion.

Voyager Therapeutics is committed to developing therapies for neurological diseases using genetic insights. Their pipeline includes programs for Alzheimer's disease, amyotrophic lateral sclerosis (ALS), Parkinson's disease, and other central nervous system disorders. Some of Voyager's projects are conducted independently, while others are in collaboration with partners like Alexion, AstraZeneca Rare Disease, Novartis Pharma AG, and Neurocrine Biosciences, Inc.