Tillman Gerngross’ Adagio Therapeutics has begun recruitment in a clinical trial of anti-SARS-CoV-2 antibody ADG20. The study is assessing the effect of a single dose of ADG20 on patients with mild to moderate COVID-19 and a high risk of disease progression.
Gerngross, the co-founder of Adimab, set up Adagio early in the pandemic to develop antibodies that neutralize SARS-CoV-2 and related coronaviruses. Adagio has retained that focus as vaccines and rival antibodies have come to market, reflecting a belief that there remains a need for its candidate in a world that faces SARS-CoV-2 variants and the persistent risk of other SARS-like viruses.
Adagio began dosing healthy volunteers with ADG20 in February, setting it up to move into a phase 1/2/3 clinical trial in COVID-19 patients. The team will assess intramuscular and intravenous doses of ADG20 against different endpoints as the study moves through its three phases.
The phase 3 part of the study is designed to show the effect of ADG20 on COVID-19 hospitalizations and all-cause death through Day 29. If the study goes to plan, Adagio expects to report initial results, which could support early patient access to ADG20, by the end of the year.
That timeline means ADG20 could come to market around one year after the first anti-SARS-CoV-2 antibodies and COVID-19 vaccines. By then, vaccination campaigns may have reduced case counts to low levels by the standards of the past year. Even so, Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio, sees a need for ADG20.
“With its potential to address resistant variants and ability to be easily administered as a low dose, affordable, intramuscular injection in the outpatient setting, ADG20 is uniquely poised to address the current need for effective, safe and convenient outpatient therapy for individuals at high risk of disease progression,” Connolly said in a statement.
ADG20 could address those needs in parts of the world where variants with some level of resistance to existing neutralizing antibodies are dominant. Having set out to develop an antibody that works against SARS-CoV-2 and other clade 1 sarbecoviruses, Adagio created a therapy that targets a highly conserved epitope that is found in COVID-19 variants.
Researchers at the University of Oxford found ADG20 maintains its potency against P.1 and B.1.351, the variants that originated in Brazil and South Africa. Adagio has previously discussed its intention to test ADG20 in countries that have high levels of resistant variants.