Biopharmaceutical firm Invivyd has dosed the first participants in a Phase I healthy volunteer trial of the new monoclonal antibody (mAb) candidate for Covid-19, VYD222.
The placebo-controlled, randomised, dose-ranging, blinded trial has been designed for assessing the pharmacokinetics, tolerability, and safety of VYD222.
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It will assess three different doses of VYD222, with each given in an IV infusion.
The company stated that all dose levels will provide durability in the face of viral evolution and flexibility during regulatory submission.
Preliminary data from the Phase I trial, which is being conducted in Australia, is expected in the second quarter, with additional clinical readouts from the VYD222 programme expected throughout the remainder of this year.
Invivyd CEO Dave Hering said: “We are excited to initiate a first in human clinical trial of VYD222.
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By GlobalData“With previously authorised mAbs losing activity against currently circulating SARS-CoV-2 variants, there is a global, urgent unmet need for new therapeutic options for vulnerable populations, including individuals who have a reduced immune response to vaccination.
“By leveraging our expertise in virology, predictive modelling and antibody engineering, VYD222 is the next of multiple candidate mAbs we aim to advance from our pipeline, with the goal of keeping pace with viral evolution and protecting the most vulnerable.”
Engineered from Invivyd’s investigational mAb adintrevimab, VYD222 is being developed to address the urgent requirement for new treatment options for vulnerable people, including immunocompromised individuals.
It also showed in vitro neutralising activity against present circulating variants of concern, including XBB.1.5.
