Independent Data Monitoring Committee Supports Expansion to Adolescents and Pregnant and Nursing Women Based on Safety and Tolerability Data from Phase 2 Lead-In
WALTHAM, Mass., Sept 13 (Bernama-GLOBE NEWSWIRE) — Adagio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today announced that the independent data monitoring committee (IDMC) for the EVADE Phase 2/3 trial of ADG20 for the prevention of COVID-19 has provided a recommendation to expand Phase 3 trial enrollment to include adolescents and pregnant or nursing women, as well as to decrease the protocol-specified, post injection monitoring time. The IDMC’s assessments are based on their review of unblinded safety and tolerability data from 200 participants enrolled in the Phase 2 lead-in portion of the trial. Adagio remains blinded to the data and plans to implement the IDMC recommendations for the Phase 3 portion of the trial. EVADE is being conducted globally, including in regions where there is a high prevalence of SARS-CoV-2 variants of concern, to evaluate the ability of a single, intramuscular dose of ADG20 to prevent COVID-19 in both pre- and post-exposure settings.
