- The U.S. government will spend nearly half of a billion dollars to support late-stage development and manufacturing of a coronavirus antibody drug being advanced by AstraZeneca, announcing an agreement with the British drugmaker Friday, just days after President Donald Trump was treated for COVID-19 with a similar drug from Regeneron.
- AstraZeneca, which is also in the final stages of testing a coronavirus vaccine, said Friday it will start in the "next weeks" two Phase 3 trials of its antibody drug combination, which it licensed from Vanderbilt University in June. The studies will enroll roughly 6,100 people in the U.S. and other countries.
- Antibody drugs, engineered to neutralize the coronavirus, are newly in the spotlight after Trump's treatment with Regeneron's experimental candidate. Both Regeneron and Eli Lilly, another antibody drug developer, have recently asked the Food and Drug Administration for emergency approval of their treatments.
AstraZeneca trailed Regeneron, Eli Lilly and, by just a few days, partners Vir Biotechnology and GlaxoSmithKline in advancing its experimental antibody drug into late-stage testing.
But AstraZeneca is only the second company to receive substantial U.S. government funding after Regeneron, which has been awarded nearly $620 million to date. Eli Lilly is working with the National Institutes of Health to test its candidate, but has not yet inked a manufacturing or supply agreement with the Trump administration.
The drugs, which consist of synthetic antibodies targeted to parts of the SARS-CoV-2 virus, could be an important tool in easing the impact of the coronavirus pandemic, particularly until an effective vaccine is found, produced and delivered at scale.
Up until now, however, the drugs have taken somewhat of a backseat to vaccines, receiving less attention — at least publicly — and far fewer dollars from the Trump administration's Operation Warp Speed project.
Trump's treatment, and subsequent promotion of Regeneron's drug, could change that, as the president pushes for the rapid deployment of antibody treatments still in testing.
"We have Regeneron. We have a very similar drug from Eli Lilly. They're coming out," he said in a video posted to Twitter after he left Walter Reed Military Medical Center. "We have hundreds of thousands of doses that are just about ready. I have emergency use authorization all set and we got to get it signed now."
Early data released by Regeneron and Lilly appeared promising, although studies are still ongoing and haven't conclusively proven a benefit to either drug.
The Trump administration's work with AstraZeneca pre-dates Trump's comments, but the announcement Friday significantly expands the government's support of the program.
Like Regeneron and Eli Lilly, AstraZeneca is testing a combination approach, using two monoclonal antibodies together in a bid for greater potency and, hopefully, lower chances the virus can evade treatment. The British drugmaker began human testing of its treatment in August, although it hasn't yet disclosed results.
The two trials planned under the collaboration with the U.S. government will test whether AstraZeneca's candidate can prevent infection or be used post exposure to reduce symptoms. The first study will enroll 4,000 patients, and the second roughly 1,100.
AstraZeneca is also planning further studies in another 4,000 patients to test its drug as a treatment for diagnosed COVID-19.
Notably, the company claims its treatment's effects can last between six and 12 months, which would give the drug greater utility as a preventive therapy if proven.
Up to 100,000 doses of the drug would be available to the U.S. government by the end of 2020, and the administration has an additional option to purchase 1 million more next year. While administration officials have said any doses acquired by the U.S. would be made available to people in the U.S. for free, AstraZeneca said it anticipates providing the drug "on commercial terms," should it win approval.
Supply will likely be a major constraint for antibody therapies, at least in the near term. Lilly said it can make about 1 million doses of its treatment available this year, while Regeneron expects to produce enough for 300,000 patients by year's end.
"We do agree that during a pandemic, and during a situation where we will likely have more demand than supply, unfortunately, it's best to partner with the government to ensure a fair allocation within the country," Lilly CEO David Ricks said this week in answering a question on whether his company would work with the Trump administration.