Policy & Regulation
Adagio Therapeutics Initiates Global Clinical Trial of ADG20 as a Treatment for COVID-19
13 April 2021 - - US-based biotechnology company Adagio Therapeutics, Inc has started 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, the company said.

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.

The STAMP trial is a global, multi-center, double-blind, placebo-controlled clinical trial evaluating ADG20 in patients with mild to moderate COVID-19 who are at high risk for disease progression.

The study will be conducted across up to 100 sites worldwide and consists of two parts. Phase 1 will assess the safety and tolerability of a single dose of ADG20 in 30 ambulatory patients with COVID-19.

Following this initial evaluation of safety, the seamless Phase 2/3 portion of the study will be initiated with the goal of preventing progression of disease, as assessed by the proportion of patients with COVID-19 related hospitalization or death within 29 days of study drug administration.

The trial is strategically designed to enable the rapid advancement of ADG20 to proof-of-concept data, which if positive, are intended to support an Emergency Use Authorization submission by the end of 2021.

The clinical development program for ADG20 includes two additional trials. A Phase 1 clinical trial of ADG20 in healthy volunteers is currently underway, evaluating the safety, tolerability, pharmacokinetics and serum SARS-CoV-2 neutralizing antibody levels of various ADG20 doses, with initial data anticipated in the second quarter of 2021.

Adagio also plans to initiate a Phase 2/3 trial (EVADE) in the prevention of COVID-19 in the second quarter of 2021.

In work recently published in Cell, researchers at the University of Oxford examined monoclonal antibody neutralization of authentic SARS-CoV-2 isolates, including Victoria (a strain similar to the original Wuhan strain) and newly emergent SARS-CoV-2 variants of concern, P.1 (originated in Brazil), B.1.351 (originated in South Africa) and B.1.1.7 (originated in the UK).

Compared with other antibodies in development, preclinical data generated demonstrate that ADG20, as well as ADG10 and ADG30, show comparable or higher potency against all three variants of concern, including those resistant to other clinical stage antibodies.

Separately, Adagio has also demonstrated that ADG20 shows no loss of binding activity against the recently emerged Southern California variant, CAL.20C, which contains the L452R mutation.

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.
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