The global, multi-centre, double-blind, placebo-controlled trial will analyse a single dose of ADG20 administered intramuscularly in two independent cohorts, post-exposure and pre-exposure prophylaxis.
The first cohort will enrol people exposed to a Covid-19 patient while the second cohort will involve people at increased risk for infection or poor response to vaccine.
EVADE will be carried out at over 100 sites across the globe and will include areas with an increased prevalence of SARS-CoV-2 virus variants.
Prevention of lab-confirmed, symptomatic Covid-19 will form the primary efficacy endpoint in the two cohorts.
Adagio commenced the EVADE trial after obtaining blinded data from ADG20’s first-in-human, randomised, placebo-controlled Phase I clinical trial in healthy subjects.
The ongoing Phase I trial is analysing the safety, tolerability, pharmacokinetics and serum SARS-CoV-2 neutralising antibody levels of different doses of the antibody treatment.
According to preliminary data, a single intramuscular ADG20 dose was well-tolerated at doses up to 600mg and its pharmacokinetic profile support an extended serum half-life, which can potentially offer protection from Covid-19 for up to a year.
Also, initial ADG20 serum virus-neutralising activity against SARS-CoV-2 is comparable to peak serum neutralising antibody titers observed in people who received a mRNA Covid-19 vaccine, Adagio said .
Adagio Therapeutics chief medical officer Lynn Connolly said: “Based on its potent and broad activity and extended duration of effect in preclinical models, we believe that ADG20 has the potential to provide both rapid protection in the face of a known, recent exposure to an individual with SARS-CoV-2 infection as well as durable protection over several months, including for individuals who are unlikely to have a sufficiently protective immune response to vaccines.”
After assessing data from the first 200 adult subjects in the Phase II part of the trial, Adagio anticipates enrolling adolescents and pregnant women in the Phase III part.