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September 30, 2021

Adagio’s ADG20 demonstrates benefit in Covid-19 clinical programme

The company intends to submit the latest data that could support a EUA application in the first quarter of next year.

Adagio Therapeutics has reported that its ADG20 monoclonal antibody demonstrated benefits in its Covid-19 clinical programme.

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ADG20 acts on the spike protein of SARS-CoV-2 and related coronaviruses and is being developed to prevent and treat Covid-19.

Updated six-month results from the company’s ongoing Phase I clinical trial in healthy subjects confirmed the prolonged half-life of ADG20.

Furthermore, the company reported data that validated the selection of the 300mg single intramuscular (IM) dose of the antibody being analysed in international Phase II/III STAMP and EVADE trials, which are underway.

The Phase I randomised, double-blind, placebo-controlled single ascending dose trial is analysing the safety and tolerability, pharmacokinetics (PK), immunogenicity and serum virus neutralising activity of ADG20 ex vivo against SARS-CoV-2.

Nearly, 50% serum virus neutralisation titers observed at six months on administering a 300mg IM dose of ADG20 were in line with reported titers with the mRNA-1273 vaccine.

In addition, the titers with ADG20 surpassed those attained with the AZD1222 vaccine series, Adagio noted.

ADG20 was well tolerated without any study drug-related adverse events (AEs), serious AEs, or injection-site or hypersensitivity reactions observed through at least three months follow-up across all groups.

Subjects will be followed up through one year to evaluate the safety and tolerability, PK, immunogenicity and serum virus-neutralising activity.

Data reported so far from the STAMP treatment trial indicate that the 300mg IM regimen could aid in quickly achieving and maintaining target concentrations at vital tissue sites of viral replication.

The EVADE prevention trial data obtained so far showed that a 300mg IM dose of ADG20 has a projected ability to quickly surpass the target serum concentrations in most of the simulated patients. It could also aid in retaining potentially efficient concentrations for up to one year.

Adagio chief medical officer Lynn Connolly said: “The continued strength of the safety and pharmacokinetic data from our Phase I study is encouraging and further underscores the potential impact an antibody such as ADG20 – which was designed to be potent, broadly neutralising and delivered as a single IM injection – could have on people with or at risk of Covid-19.

“This Phase I data, combined with our dose selection strategy, which relied on our innovative modelling approach, have allowed us to initiate and advance our pivotal trials of ADG20 in the treatment and prevention of Covid-19.”

The company noted that these data could support an emergency use authorization (EUA) application in the first quarter of next year.

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