- Adagio Therapeutics said Wednesday it has started a massive Phase 2/3 trial designed to see whether its antibody drug, ADG20, can prevent symptomatic coronavirus disease.
- The study, named EVADE, is a roughly 6,400-participant trial enrolling people at high risk for COVID-19, as well as patients who have been exposed to someone infected with the virus that causes it. In both cases, researchers are measuring the effects of Adagio's antibody drug against a placebo.
- The trial has begun less than a month after Adagio raised an unusually large financing round that could set the stage for an initial public offering. Adagio aims to show that its drug has key advantages over established, rival medicines from Regeneron and Eli Lilly, though it's unclear what type of market will remain for the company should ADG20 succeed in clinical testing.
Adagio is wasting no time using the $336 million it raised in a major financing round this year.
The Massachusetts-based company is betting it can carve out a role for ADG20 even after a significant head start by much larger drugmakers like Eli Lilly and Regeneron. With the epidemic still raging globally and variants a major concern, Adagio CEO Tillman Gerngross said Wednesday his company believes "a broadly neutralizing therapy that could be given for both treatment and prevention will be necessary."
Adagio's antibody is delivered through a single intramuscular injection, not an intravenous infusion or multiple shots like the others. Phase 1 testing has showed it can provide as much as 12 months of protection against COVID-19, suggesting it may last longer than its rivals. And ADG20 binds to a different target than Regeneron or Lilly's drugs, which, its makers claim, suggests it could neutralize a variety of coronaviruses and remain potent against variants.
Adagio said it may open its latest study to pregnant women and adolescents after an initial evaluation of 200 adults. The company is also continuing its Phase 1 research, and a trial known as STAMP that's looking at the benefits of its antibody in treating high-risk patients with mild or moderate cases of COVID-19.
Still, a lingering question for Adagio is how much of the market share its COVID-19 treatment could carve out. Lilly and Regeneron already have clearance from the Food and Drug Administration to sell their antibody treatments, and a third option from Vir Biotechnology and GlaxoSmithKline is close behind.
At the same time, Lilly and Regeneron have run into challenges selling their antibody therapies. These treatments have been "underutilized," according to U.S. health authorities, in large part because they can be tricky to administer.
Lilly has also started to see its COVID-19 antibodies generate less revenue. The pharma giant logged $810 million in revenue from them during the first quarter, compared with $871 million in the fourth quarter of 2020.
Last month, the FDA removed the emergency authorization given to Lilly's first marketed COVID-19 therapy, known as bamlanivimab. Lilly made the request just weeks after the U.S. government chose to stop distributing the antibody over concerns that it wasn't effective against coronavirus variants.
Lilly still sells bamlanivimab, but as part of a two-antibody cocktail that's been shown to help prevent coronavirus disease and cut the risk of the worsening symptoms.