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Invivyd Doses First Participants in Phase 1 Trial of VYD222, a Novel Monoclonal Antibody Candidate for COVID-19
A clinical trial generating safety, pharmacokinetics, and dosing data with the goal of providing information to allow for rapid advancement into a pivotal
About this update from Invivyd, Inc.
[{"type":"text","content":"A clinical trial generating safety, pharmacokinetics, and dosing data with the goal of providing information to allow for rapid advancement into a pivotal Phase 3 trial\nWALTHAM, Mass., March 30, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced dosing of the first participants in a Phase 1 healthy volunteer trial of VYD222, a novel monoclonal antibody (mAb) candidate for COVID-19. The Phase 1 randomized, blinded, placebo-controlled, dose-ranging trial will evaluate the safety, pharmacokinetics, and tolerability of VYD222 (NCT05791318). The dose-ranging trial will evaluate three different doses, each administered in an IV infusion. All dose levels are designed to provide durability in the face of viral evolution and flexibility at the time of regulatory submission. This Phase 1 trial is being conducted in Australia. The company expects preliminary data readouts from the Phase 1 trial in the second quarter and anticipates additional clinical readouts from the VYD222 program throughout the remainder of 2023. “We are excited to initiate a first in human clinical trial of VYD222,” said Dave Hering, chief executive officer of Invivyd. “With previously authorized 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 modeling 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.” About VYD222VYD222 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to address the urgent need for new therapeutic options for vulnerable populations, including immunocompromised people. Globally, there are millions of immunocompromised people, with an estimated 8 million in the U.S. alone, who may not adequately respond to COVID-19 vaccination, increasing their risk for severe outcomes from COVID-19. As of March 2023, there are no monoclonal antibodies authorized or approved in the U.S. for the prevention or treatment of C...