Invivyd has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for VYD222 to prevent Covid-19.
VYD222 is a new monoclonal antibody (mAb) candidate and is being developed to prevent Covid-19 in vulnerable people, including immunocompromised individuals.
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Engineered from adintrevimab (ADG20), the antibody showed in vitro neutralising activity against dominant variants of concern, including XBB.1.5.
It is being assessed in an ongoing Phase I healthy volunteer clinical trial in Australia.
The company commenced dosing participants in March 2023.
Invivyd chief medical officer Pete Schmidt said: “For the millions of immunocompromised people around the world who may not generate adequate protection from SARS-CoV-2 vaccines, there is an urgent need for new therapeutics that provide the rapid, passive immunity that results from the direct delivery of mAbs.
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By GlobalData“With the previously authorised anti-SARS-CoV-2 mAbs losing activity against current variants of concern, we look forward to continuing to work with the FDA and global regulators to advance VYD222 and our platform-based approach to development.”
The dose-ranging, blinded, placebo-controlled, randomised Phase I trial has been designed for assessing the pharmacokinetics, tolerability, safety and serum virus-neutralising activity of VYD222 in healthy adult volunteers.
The trial will assess three different doses of VYD222, each administered as a single IV infusion.
The company stated that all dose levels will provide durability in the face of viral evolution and flexibility during the regulatory submission.
