Preclinical and clinical data for CT1812 demonstrated that its selective binding to the sigma-2 (σ-2) receptor complex resulted in the displacement of toxic Aβ oligomers. Image credit: Robert Kneschke / Shutterstock.

Voyager Therapeutics has dosed the first patient in a Phase Ia single-ascending dose study of its investigational anti-tau antibody VY-TAU01 for patients with Alzheimer’s disease. 

The trial will be a randomised, double-blind, placebo-controlled study evaluating the safety and pharmacokinetics of VY-TAU01 in 48 healthy adults. Patients will be randomised to receive intravenously delivered candidate or a placebo. The company plans to initiate a Phase Ib multiple-ascending dose study in 2025, following data from the Phase Ia trial. 

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The study is indicated to produce initial tau positron emission tomography (PET) imaging data in the second half of 2026. This will indicate if VY-TAU01 can slow the spread of pathological tau in the brain, according to the US-based biotech. Tau proteins help stabilise the structure of neurons, but in Alzheimer’s, they become tangled, disrupting cell function. These tangles are a hallmark of Alzheimer’s and are thought to correlate with the severity of cognitive decline. 

The only approved drug that slows Alzheimer’s disease progression and cognitive and functional decline is Biogen and Eisai’s Leqembi (lecanemab). Leqembi targets the amyloid protein pathway, another marker of Alzheimer’s. Anti-tau antibodies have not had much success to date, with Eli Lilly halting the development of zagotenemab after a Phase II trial with the the monoclonal antibody missed its primary endpoint in 2021. 

VY-TAU01 is a vectorised version of an anti-tau monoclonal antibody. Voyager has several other candidates in the pipeline, many of which are developed using its TRACER technology. The discovery platform allows for the discovery of AAV capsids which can cross the blood-brain barrier and target the central nervous system. 

Pharma giant Novartis signed a collaboration and capsid license agreement with Voyager in January 2024 worth $1.3bn. The pair teamed up to develop gene therapies for Huntington’s disease and spinal muscular atrophy (SMA). This partnership builds on a previous collaboration in 2022, where Novartis could exercise options to license three adeno-associated virus (AAV) capsids for potential use in gene therapies for three undisclosed neurological disease targets. 

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In the announcement accompanying the trial initiation, Voyager’s chief medical officer Toby Ferguson 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.” 

A GlobalData report predicts that the global Alzheimer’s market will be worth $15.9bn in 2030.  

GlobalData is the parent company of Clinical Trials Arena.