The Phase 2 clinical trial is expected to be initiated by mid-2026 and to include the following features:
-Multiple high doses of highly active monoclonal antibody VYD2311, an investigational antibody that has demonstrated in vitro antiviral activity across all clinically recorded variants of SARS-CoV-2 tested since the original Wuhan strain, across many months of therapy
-Double-blind, placebo control
-Inclusion criteria designed to enroll people with demonstrated persistent infection or antigenemia, to the extent technologically possible
Clinical efficacy evaluations including functional performance tests and Patient-Reported Outcomes assessment (PROs) consistent across prior studies of Long COVID and other infection-associated chronic conditions and illnesses
“Not long after launching PEMGARDA® (pemivibart) for the prevention of COVID in certain immunocompromised people, we became aware of increasing, independent case reports of Long COVID treatment successes, as we previously noted,” said Marc Elia, Chairman of Invivyd’s Board of Directors. “These reports echo earlier work with other monoclonal antibodies and, along with continuously emerging reports and observations of chronic infection, give us confidence to explore this potential therapeutic signal in a prospective, placebo-controlled study, especially given the strong and broad antiviral activity we have observed with VYD2311. With the SPEAR Study Group, we believe we have the partnership of the leading minds in Long COVID and COVID vaccine injury, and we are looking forward to expanding our work radically for the benefit of people suffering from Long COVID, if we generate a meaningful signal of therapeutic benefit.”
Further details on the planned Phase 2 Long COVID trial of VYD2311 are expected to be made available in coming months, including details on
www.clinicaltrials.gov when possible.