Core Insights - Invivyd, Inc. has received FDA clearance for its Investigational New Drug application to advance the REVOLUTION clinical program for VYD2311, a monoclonal antibody candidate aimed at preventing COVID-19 [1][2] Clinical Trials Overview - The DECLARATION clinical trial is a Phase 3 pivotal trial designed to evaluate the safety and efficacy of VYD2311 against a placebo, focusing on the prevention of symptomatic COVID-19 [2][5] - The LIBERTY clinical trial will compare the safety and tolerability of VYD2311 against mRNA-based COVID vaccines and will explore the co-administration of VYD2311 with vaccination [2][4] - Both trials are expected to start around the end of 2025, with top-line data anticipated by mid-2026 [5][6] Trial Design and Objectives - The DECLARATION trial will assess the prevention of symptomatic COVID-19 at three months with either a single dose or monthly doses of VYD2311, administered via intramuscular injection [3][5] - The LIBERTY trial aims to demonstrate the safety and tolerability advantages of antibody-based prophylaxis compared to mRNA vaccines, and to gather data on the interaction between VYD2311 and mRNA vaccines [4][5] Strategic Goals - The REVOLUTION program aims to provide at-risk populations with a flexible and safe alternative for COVID-19 protection, allowing individuals to choose the timing and quantity of their protection [6][8] - Invivyd has produced commercial launch quantities of VYD2311 and secured funding to support the execution of clinical trials [6][10] Product Information - VYD2311 is a novel monoclonal antibody candidate developed to address the urgent need for new prophylactic options against COVID-19, with a focus on delivering clinically meaningful titer levels through patient-friendly administration [8][9] - The antibody is engineered using Invivyd's proprietary technology platform, optimized for neutralizing contemporary virus lineages [9][10]