Adagio Therapeutics expands patient population in global Phase 2/3 clinical trial of ADG20 for COVID

KUALA LUMPUR, Sept 13 -- Adagio Therapeutics Inc announced 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 enrolment to include adolescents and pregnant or nursing women, as well as to decrease the protocol-specified, post injection monitoring time.

ADG20, a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is being developed for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2.

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, according to a statement.

The clinical-stage biopharmaceutical company, 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.

The EVADE trial is a global, multi-centre, double-blind, placebo-controlled clinical trial evaluating ADG20 in two independent cohorts.

The first cohort (post-exposure prophylaxis) is designed to assess the safety and efficacy of ADG20 compared to placebo for the prevention of COVID-19 after exposure to an individual with laboratory confirmed SARS-CoV-2 infection.

Meanwhile, the second cohort (pre-exposure prophylaxis) is designed to assess the efficacy and safety of ADG20 compared to placebo in individuals who are at increased risk for SARS-CoV-2 infection due to occupational, housing or recreational situations, and in individuals who are at increased risk of poor vaccine response.

The clinical development programme for ADG20 includes two additional trials: the ongoing Phase 1 clinical trial of ADG20 in healthy volunteers and the ongoing STAMP trial evaluating ADG20 as a treatment for high-risk individuals with mild or moderate COVID-19.

More details at www.adagiotx.com.

-- BERNAMA