Invivyd has dosed the first patient in the Phase III CANOPY clinical trial of VYD222 for the prevention of symptomatic Covid-19.
The pivotal trial is designed to assess the pharmacokinetics, tolerability, safety, and immunogenicity of VYD222, as well as to evaluate its protection against symptomatic patients.
Approximately 750 participants are expected to be randomised into two cohorts and the study will be carried out in parallel across various sites in the US.
Cohort A intends to enrol nearly 300 participants who are significantly immunocompromised.
In this cohort, serum neutralising titers against relevant SARS-CoV-2 variants are used to assess the primary efficacy endpoint at day 28.
Cohort B will enrol approximately 450 patients who are at risk of exposure to SARS-CoV-2. They will be randomised into a 2:1 ratio to receive VYD222 or a placebo.
Both cohorts will receive VYD222 4500mg through intravenous infusion.
Evaluating the tolerability and safety is the primary endpoint for both the cohorts. The initial primary endpoint data is anticipated late this year or in the early first quarter of next year.
Invivyd CEO Dave Hering said: “The initiation of the CANOPY pivotal clinical trial marks a major milestone for Invivyd and it is a significant step in our journey to rapidly advance VYD222 toward a potential EUA submission.
“Thanks to the hard work and dedication of our teams, Invivyd is at the forefront of advancing new therapeutics to address circulating viral threats.”
A broadly neutralising, half-life extended monoclonal antibody candidate, VYD222 demonstrated in vitro neutralising activity against various pre-Omicron and Omicron variants, such as XBB.1.5 and XBB.1.5.10.
