Adagio Therapeutics’ COVID-19 antibody drug could provide as much as 12 months of protection against infection with the coronavirus, according to an early-stage clinical trial, supporting advancement of the therapy to phase 2/3.
Waltham, Massachusetts-based Adagio has now dosed the first patient in that pivotal trial, called EVADE, which is evaluating ADG20 for its ability to prevent COVID-19 in pre- and post-exposure settings.
The advancement comes a few weeks after the 2020 Fierce 15 winning biotech announced a monster $336 million series C fundraising, as Adagio tries to position itself to advance a preventive treatment for the global pandemic and perhaps even rival the protection seen from vaccines, with potentially a cleaner safety profile.
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To truly see that, we'll need it to do those bigger tests, but for now things looking promising: In the ongoing phase 1 trial, Adagio found ADG20 was safe and tolerable at several different doses up to 600 mg. The study also revealed the therapy could provide protection for as long as 12 months and that the protection was similar to that seen in patients who received one of the mRNA vaccines available to prevent COVID-19. Those two vaccines, of course, are made by Pfizer-BioNTech and Moderna.
“Based on its potent and broad activity and extended duration of effect in preclinical models, we believe that ADG20 has the potential to provide both rapid protection in the face of a known, recent exposure to an individual with SARS-CoV-2 infection as well as durable protection over several months, including for individuals who are unlikely to have a sufficiently protective immune response to vaccines,” said Lynn Connolly, M.D., Ph.D., Adagio’s chief medical officer. “We appreciate the enthusiasm expressed by our investigators and their support in advancing this differentiated antibody therapy.”
Adagio will study two different groups in the EVADE trial. One arm will survey the safety and tolerability of ADG20 compared to placebo in preventing COVID-19 after exposure to a person with a lab-confirmed case of the respiratory disease. The second group will determine whether ADG20 can prevent infection in patients who are at high risk for exposure through their work or housing situation or in those with compromised immune systems or other health problems that raise the risk.
Once 200 people are enrolled in the study, Adagio may open it up to adolescents and pregnant women—two groups testing of preventive COVID-19 therapies has been slow to reach. Many pregnant women are getting vaccines along with advice from their physicians, but some data in this area would help shore up concerns. Vaccines for preventing COVID-19 are so far only approved in the U.S. for those 16 and older. Many companies, including Moderna, are currently conducting trials testing the efficacy and safety in younger children.
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The ultimate goal in Adagio's midstage trial is to prevent lab-confirmed and symptomatic COVID-19 infection. A separate trial, called STAMP, is evaluating ADG20 as a treatment for high-risk patients with mild or moderate COVID-19.
Coming up with an effective and easy to administer antibody treatment has proven challenging for the pharmaceutical industry, which has been scrambling against the rise of coronavirus variants that have brought on a resurgence of the pandemic around the world. Some treatments have advanced to receive emergency use authorization, only to see the new variants render them mostly useless on their own, as was the case with a therapy called bamlanivimab put forward by Eli Lilly. The company and its partner AbCellera are now racing to tweak the formula with antibodies that target the variants.