The Phase 2 FLINTLOCK clinical trial includes the following study features:
Randomized, double-blind, placebo-controlled, proof-of-concept study
Tests Invivyd’s monoclonal antibody VYD2311, an investigational monoclonal antibody that has been demonstrated to be pharmaceutically active against all SARS-CoV-2 variants tested to date from current variants back to original Wuhan variants
High-dose initial intravenous (IV) infusion of VYD2311 followed by monthly intramuscular (IM) injections at days 30 and 60 with total dose targeted at 10x the prophylactic dose of VYD2311 assessed in DECLARATION and LIBERTY, while still below doses already assessed with a positive initial safety profile in VYD2311 first-in-human testing (LINK)
Inclusion criteria designed to enroll adults aged 18-65 years with confirmed Long COVID or PVS; criteria include having at least 2 persistent symptoms after a COVID-19 infection or following COVID-19 vaccine injury
Clinical efficacy evaluations include functional performance tests consistent across prior studies of Long COVID and other infection-associated chronic conditions and illnesses, through Day 90
Assessment of the safety and tolerability of VYD2311 based on the incidence, severity, causality, and outcome of treatment emergent adverse events (TEAEs) and hypersensitivity reactions through Day 90, as well as evaluation of the pharmacokinetics of VYD2311 by measuring serum concentrations through Day 90
Initial data expected in mid-2027.
Further details on the FLINTLOCK Phase 2 Long COVID trial of VYD2311 will be posted near-term to www.clinicaltrials.gov.
PEMGARDA® (pemivibart) is not authorized or approved for the treatment of Long COVID or PVS.