Policy & Regulation
Adagio Therapeutics begins global clinical trial of ADG20 for the treatment of COVID-19
14 April 2021 -

Biotechnology company Adagio Therapeutics Inc on Tuesday announced the launch of its Phase 1/2/3 clinical trial, called the STAMP trial, to evaluate the ability of a single dose of ADG20 to prevent COVID-19 related hospitalizations and death.

ADG20 is a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses and is being developed for the treatment of COVID-19. 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, said the company.

This STAMP trial will be conducted globally, including in regions with a high prevalence of SARS-CoV-2 variants of concern. 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 company said STAMP is a global, multi-centre, double-blind, placebo-controlled clinical trial conducted across 100 sites in two parts. Phase 1 will assess the safety and tolerability of a single dose of ADG20 in 30 ambulatory patients with COVID-19. The Phase 2/3 portion of the study will be initiated with the goal of preventing progression of disease within 29 days of study drug administration.

Compared with other antibodies in development, the preclinical data generated demonstrate that the company's ADG20 show comparable or higher potency against the newly emergent SARS-CoV-2 variants of concern, P.1 Brazil), B.1.351 (South Africa) and B.1.1.7 (the UK).

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