Adagio Therapeutics announces ADG 20 Phase 1 data and initiation of global phase II/III clinical trial of ADG 20 for the prevention of COVID-19.

Adagio Therapeutics, Inc., a biotechnology company developing highly differentiated antibodies to broadly neutralize coronaviruses, announced that the first patient has been treated in the company’s Phase II/III pivotal trial evaluating ADG 20 for the prevention of COVID-19, known as the EVADE trial. Trial initiation is supported by positive preliminary data from the company’s ongoing Phase 1 trial in healthy volunteers.EVADE will be conducted globally at more than 100 sites, including in regions where there is a high prevalence of SARS-CoV-2 variants of concern, and will evaluate the ability of a single, intramuscular dose of ADG 20 to prevent COVID-19 in both pre- and post-exposure settings. The initiation of the EVADE trial is supported by blinded data from Adagio’s ongoing first-inhuman, randomized, placebo-controlled Phase 1 clinical trial. The Phase 1 trial was designed to evaluate the safety, tolerability, pharmacokinetics and serum SARS-CoV-2 neutralizing antibody levels of various ADG 20 dose regimens. Preliminary data demonstrate that a single intramuscular injection of ADG 20 is well tolerated at doses up to 600 mg, and the initial pharmacokinetic profile support a prolonged serum half-life, which has the potential to afford up to 12 months of protection against COVID-19. In addition, initial ADG 20 serum virus neutralizing activity against authentic SARS-CoV-2 is similar to peak serum neutralizing antibody titers reported for mRNA COVID-19 vaccine recipients.