Invivyd Announces Initiation of DECLARATION Clinical Trial, a Phase 3 Placebo-Controlled Pivotal Study of VYD2311, a Vaccine-Alternative Antibody to Prevent COVID

Core Insights - Invivyd, Inc. has initiated the DECLARATION trial to evaluate VYD2311, a monoclonal antibody candidate for COVID prevention, marking a significant milestone in the company's efforts to provide a vaccine-alternative option for protection against COVID [1][2] Group 1: Trial Details - The DECLARATION study is a Phase 3, randomized, triple-blind, placebo-controlled trial aimed at assessing the efficacy and safety of VYD2311 in preventing symptomatic COVID in a diverse population, including adults and adolescents [6] - The trial will compare a single intramuscular (IM) dose and monthly doses of VYD2311 against a placebo, with a total expected enrollment of 1770 participants [5][6] - The primary endpoint is the reduction of PCR-confirmed symptomatic COVID incidence compared to placebo, with top-line data anticipated by mid-2026 [5][6] Group 2: VYD2311 Overview - VYD2311 is designed to address the urgent need for new prophylactic and therapeutic options for COVID-19, with a pharmacokinetic profile that may allow for effective delivery through intramuscular administration [3] - The monoclonal antibody was engineered using Invivyd's proprietary technology platform, optimized for neutralizing contemporary virus lineages, and shares the antibody backbone with other investigational mAbs that have received emergency use authorization [4] Group 3: Company Positioning and Strategy - Invivyd has produced commercial launch quantities of VYD2311 and has secured significant capital to support the DECLARATION study and potential commercial launch [2] - The company aims to provide flexible dosing options, allowing individuals to choose between a single dose or periodic extra protection, which could be particularly beneficial for at-risk populations [2][5]