Adagio Therapeutics, Inc., today announced the initiation of recruitment in its Phase 1/2/3 clinical trial to evaluate ADG20 as a treatment for high-risk individuals with mild or moderate COVID-19. Known as the STAMP trial, this pivotal study will be conducted globally, including in regions with a high prevalence of SARS-CoV-2 variants of concern. The goal of the trial is to evaluate the ability of a single dose of ADG20 to prevent COVID-19 related hospitalizations and death. The company anticipates reporting initial results, with the potential for early patient access to treatment based on these data, by the end of 2021.
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. ADG20 was designed and engineered to possess high potency and broad neutralization against SARS-CoV-2 and additional clade 1 sarbecoviruses, by targeting a highly conserved epitope in the receptor binding domain. ADG20 displays potent neutralizing activity against the original SARS-CoV-2 strain as well as all known variants of concern. ADG20 has the potential to impact viral replication and subsequent disease through multiple mechanisms of action, including direct blocking of viral entry into the host cell (neutralization) and elimination of infected host cells through Fc-mediated innate immune effector activity. ADG20 is formulated at high concentrations, enabling intramuscular administration for both prevention and treatment of COVID-19, and was engineered to have a long half-life, allowing for immediate and durable protection. Adagio is advancing ADG20 through multiple clinical trials on a global basis.