FDA clearance paves the way for Invivyd to launch 2 phase 3 trials of VYD2311, a monoclonal antibody designed as a safe, convenient, vaccine alternative for COVID-19 prevention.
Invivyd recently announced that the FDA has cleared the company’s Investigational New Drug (IND) application for VYD2311, a monoclonal antibody candidate designed as a vaccine alternative for the prevention of COVID-19. The FDA also provided feedback supporting advancement of Invivyd’s REVOLUTION clinical program.
The REVOLUTION program will launch two key studies: DECLARATION and LIBERTY.
Invivyd plans to initiate both trials by the end of 2025, with top-line data anticipated in mid-2026. Pending regulatory approval, additional studies may follow to further characterize VYD2311’s long-term protective profile and potential use in pediatric and other populations.
The Phase 3 DECLARATION and LIBERTY trials will evaluate VYD2311’s safety, efficacy, and potential role as a non-vaccine option for COVID-19 prevention.
The REVOLUTION program seeks to give individuals flexibility in how and when they protect themselves from COVID-19, including annual, semi-annual, or situational dosing options.
Antibody-based prophylaxis could complement vaccine-based strategies, offering durable, low-inflammation protection for at-risk populations.
“We are moving as fast as possible to bring Americans a new choice in protection from COVID,” Marc Elia, chairman of Invivyd’s Board of Directors, said in a statement. “Our goal is to provide a safe, convenient alternative for those seeking protection without repeated exposure to inflammatory vaccines. The DECLARATION and LIBERTY trials are designed to empower individuals to choose when and how they protect themselves—whether annually, during periods of elevated risk, or around important life events. Antibody-based prevention builds on natural human immunity and could serve as a first-line option for millions.”
Invivyd has already manufactured commercial-scale quantities of VYD2311 and secured sufficient funding to support clinical execution through pivotal data readouts.
The company plans to share additional details on the REVOLUTION clinical program—including trial design rationale, dosing strategy, endpoints, and commercial outlook—at an upcoming investor event later this month.
Check out this previous interview with Invivyd’s Chief Scientific Officer Robert Allen, PhD, as he discusses the company’s pemivibart (Pemgarda) including its administration, how it can be used in concert with vaccines, and how it protects against newer variants.
VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration.
VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the US. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19.
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