Adagio(US:IVVD) Globenewswireยท2025-09-04 11:01Core Viewpoint - Invivyd, Inc. announced that the SPEAR Study Group has issued a consensus recommendation for a clinical study design to evaluate monoclonal antibody therapy for Long COVID, which will be presented to the NIH initiative RECOVER-TLC [1][2]. Group 1: Study Design and Objectives - The SPEAR Study Group aims to explore the role of persistent viral reservoirs and circulating spike protein in Long COVID through a proposed clinical study focusing on broadly neutralizing anti-SARS-CoV-2 spike protein monoclonal antibodies, including VYD2311 [2][5]. - Key elements of the proposed clinical study include deploying high levels of neutralizing monoclonal antibodies over the long term, a randomized placebo-controlled design with over 100 patients per arm, and measuring reduction in detectable spike antigen as a critical endpoint [6][5]. - The study will also explore potential symptom improvement using standardized instruments to correlate the modification of underlying chronic infection with clinical benefits [6][5]. Group 2: Presentation and Workshop - 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 [3]. - Dr. David Putrino will present the study design for funding consideration on September 10, 2025, at 9:25 a.m. ET, while Dr. Amy Proal will discuss the antiviral landscape and implications for Long COVID research later that day at 1:00 p.m. ET [3]. Group 3: VYD2311 Overview - VYD2311 is a novel monoclonal antibody candidate developed to address the urgent need for new therapeutic options for COVID-19, with a pharmacokinetic profile that may allow for patient-friendly administration [7][8]. - The antibody was engineered using Invivyd's proprietary technology platform and is designed to neutralize contemporary virus lineages, leveraging the same backbone as other investigational mAbs with emergency use authorization [8][9].