10.09.2021 13:10:02
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Adagio Therapeutics Expands Patient Population In ADG20 Trial For COVID-19
(RTTNews) - Adagio Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced Friday the expansion of patient population in global EVADE phase 2/3 clinical trial of ADG20 for the prevention of COVID-19.
The EVADE global trial is a global, multi-center, double-blind, placebo-controlled clinical trial evaluating ADG20 in two independent cohorts. It evaluates the ability of a single, intramuscular dose of ADG20 to prevent COVID-19 in both pre- and post-exposure settings.
The independent data monitoring committee or IDMC for the trial has provided a recommendation to expand Phase 3 trial enrollment to include adolescents and pregnant or nursing women. The IDMC also recommended 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 said it plans to implement the IDMC recommendations for the Phase 3 portion of the trial.
Lynn Connolly, chief medical officer of Adagio, said, "Based on the potent and broad activity of ADG20 in non-clinical studies, as well as its extended half-life and ease of administration, we believe this antibody has the potential to become a preferred prophylactic option for COVID-19, particularly for vulnerable groups such as children and the immunocompromised, for whom there are currently limited or no available options."
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