NEW HAVEN, Conn. — January 20, 2026 — Leads & Copy —
Invivyd, Inc. (Nasdaq: IVVD) and the SPEAR Study Group have announced plans to initiate a Phase 2 clinical trial to assess the monoclonal antibody VYD2311 in individuals with Long COVID or COVID vaccine injury.
The trial aims to evaluate the safety, translational biology, and exploratory clinical efficacy of VYD2311. Participants will include individuals with Long COVID who show evidence of chronic infection or antigen persistence in various tissues, as well as those with COVID vaccine injuries who have demonstrated persistence of vaccine-delivered spike protein.
The study design involves administering multiple high doses of highly active antibody VYD2311 over an extended period to assess its safety and potential clinical benefits compared to a placebo.
Dr. David Putrino, Nash Family Director of the Cohen Center for Recovery from Complex Chronic Illness at Mount Sinai and Founding Member of the SPEAR Study Group, stated that data indicates protracted infection and/or prolonged presence of spike protein antigen in people living with Long COVID. He also noted that spike protein has been found in the blood of some people who report a chronic debilitating condition after COVID vaccination.
Dr. Amy Proal, CEO of PolyBio Research Foundation and founding member of the SPEAR Study Group, believes that chronic exposure to SARS-CoV-2 spike protein may be driving ongoing morbidity in America. She expressed optimism that the monoclonal antibodies discovered and developed by Invivyd could potentially halt and reverse some of the damage.
The Phase 2 clinical trial, expected to commence by mid-2026, will feature multiple high doses of VYD2311, a monoclonal antibody with in vitro antiviral activity across all clinically recorded variants of SARS-CoV-2 tested since the original Wuhan strain. The trial will be double-blind and placebo-controlled, with inclusion criteria designed to enroll individuals with demonstrated persistent infection or antigenemia.
Clinical efficacy evaluations will include functional performance tests and Patient-Reported Outcomes assessment (PROs) consistent across prior studies of Long COVID and other infection-associated chronic conditions and illnesses.
Marc Elia, Chairman of Invivyd’s Board of Directors, noted reports of Long COVID treatment successes with PEMGARDA® (pemivibart) and expressed confidence in exploring the potential therapeutic signal of VYD2311, given its strong and broad antiviral activity.
Further details on the planned Phase 2 Long COVID trial of VYD2311 are expected to be released in the coming months and will be available on www.clinicaltrials.gov when possible.
VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19.
PEMGARDA® (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC, LP.8.1 and XFG.
The SPEAR (Spike Protein Elimination and Recovery) Study Group was formed by Invivyd and leading researchers to assess the effects of monoclonal antibody (mAb) therapy for Long COVID and COVID-19 Post-Vaccination Syndrome.
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company focused on delivering protection from serious viral infectious diseases, starting with SARS-CoV-2.
Contacts:
Media Relations
(781) 208-0160
media@invivyd.com
Investor Relations
(781) 208-1747
investors@invivyd.com
Source: Invivyd, Inc.
