WALTHAM, Mass. — September 4, 2025 — Leads & Copy — Invivyd, Inc. (Nasdaq: IVVD) announced today that the SPEAR Study Group has issued its consensus recommendation for a clinical study design to evaluate the effects of monoclonal antibody (mAb) therapy on Long COVID, which will be presented to RECOVER-TLC, an NIH initiative.
The SPEAR Study Group, comprised of leading investigators, focuses on designing studies that explore the role of persistent viral reservoirs or circulating spike protein in driving Long COVID. The proposed clinical study centers on anti-SARS-CoV-2 spike protein monoclonal antibodies, including VYD2311, as potential therapies for Long COVID or Post-Vaccination Syndrome (PVS).
Key elements of the proposed clinical study include deploying high levels of neutralizing monoclonal antibody over months, a randomized, placebo-controlled study with over 100 patients per arm, enrollment based on biomarkers indicating persistent spike antigen, measuring reduction in detectable spike antigen as the critical translational endpoint, and exploring potential symptom improvement using standardized instruments.
Drs. Amy Proal and David Putrino will present the proposed study design at the Second Annual RECOVER-TLC Workshop on September 9-10, 2025, in Bethesda, Maryland. Dr. Putrino will present on September 10 at 9:25 a.m. ET, and Dr. Proal will discuss the antiviral landscape and implications for Long COVID research on September 10 at 1:00 p.m. ET.
VYD2311 is a novel monoclonal antibody candidate developed for COVID-19, engineered using Invivyd’s technology platform. It leverages the same antibody backbone as pemivibart and adintrevimab.
Invivyd, Inc. is a biopharmaceutical company focused on delivering protection from serious viral infectious diseases.
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Source: Invivyd, Inc.
