eClinical Technology and Industy News

Adagio Therapeutics Announces ADG20 Phase 1 Data and Initiation of Global Phase 2/3 Clinical Trial of ADG20 for the Prevention of COVID-19

Excerpt from the Press Release:

WALTHAM, Mass.–(BUSINESS WIRE)–Adagio Therapeutics, Inc., a biotechnology company developing highly differentiated antibodies to broadly neutralize coronaviruses, today announced that the first patient has been treated in the company’s Phase 2/3 pivotal trial evaluating ADG20 for the prevention of COVID-19, known as the EVADE trial. Trial initiation is supported bypositive 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 ADG20 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-in-human, 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 ADG20 dose regimens. Preliminary data demonstrate that a single intramuscular injection of ADG20 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 ADG20 serum virus neutralizing activity against authentic SARS-CoV-2 is similar to peak serum neutralizing antibody titers reported for mRNA COVID-19 vaccine recipients.

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