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Invivyd and SPEAR Study Group Announce Plan for Phase 2 Study of VYD2311 for Treatment of Long COVID and COVID Vaccine-Injured Individuals to Commence Mid-2026
Globenewswire· 2026-01-20 12:01
Core Viewpoint - Invivyd, Inc. and the SPEAR Study Group are set to initiate a Phase 2 clinical trial for the monoclonal antibody VYD2311, targeting individuals suffering from Long COVID or COVID vaccine injury, addressing a significant unmet medical need in the U.S. [1][2] Group 1: Clinical Trial Details - The Phase 2 clinical trial is expected to start by mid-2026 and will evaluate the safety, translational biology, and exploratory clinical efficacy of VYD2311 in individuals with Long COVID or COVID vaccine injury [4][5] - Participants will include those with Long COVID showing evidence of chronic infection or antigen persistence, as well as individuals injured by COVID vaccines [4] - The trial design includes administering multiple high doses of VYD2311 over the long term to assess safety and potential clinical benefits compared to a placebo [4][5] Group 2: Scientific Rationale - Data indicates that prolonged presence of spike protein antigen may contribute to ongoing morbidity in individuals with Long COVID and those experiencing chronic conditions post-vaccination [2] - The SPEAR Study Group was formed to advance understanding of Long COVID and explore potential therapeutic options, with Invivyd's monoclonal antibodies seen as promising candidates [2][3] Group 3: Product Information - VYD2311 is a novel monoclonal antibody candidate developed to address the urgent need for new therapeutic options for COVID-19, demonstrating in vitro antiviral activity against all clinically recorded variants of SARS-CoV-2 [6][7] - The antibody was engineered using Invivyd's proprietary technology platform, optimized for neutralizing contemporary virus lineages [7] - VYD2311 aims to deliver clinically meaningful titer levels through more patient-friendly administration methods, such as intramuscular injection [6]