AstraZeneca is planning two late-stage trials of its coronavirus antibody drug with support from the feds after President Trump praised a similar treatment for helping him shake the virus.
The so-called Phase 3 studies of the drug involving more than 6,000 people will start in the coming weeks after AstraZeneca received a $486 million funding commitment from Operation Warp Speed, the Trump administration’s initiative to speed up development of treatments and vaccines for COVID-19, the British drugmaker said Monday.
“This agreement with the US government will help accelerate the development of our long-acting antibody combination which has the potential to provide immediate and long-lasting effect in both preventing and treating COVID-19 infections,” AstraZeneca CEO Pascal Soriot said in a statement.
One study will test whether the medicine is safe and effective at preventing infection for up to 12 months in about 5,000 participants, while the other study involving about 1,100 volunteers will examine whether it can prevent people from becoming infected after they’ve been exposed to someone with COVID-19.
AstraZeneca said it is planning additional trials with about 4,000 patients to evaluate whether the drug can treat the coronavirus.
The company plans to supply the US government with up to 100,000 doses of the drug, known as AZD7442, starting later this year. The feds will have the option to buy up to 1 million additional doses in 2021 under a separate deal, AstraZeneca said.
President Trump has touted antibody treatments since he was given a similar drug made by New York-based Regeneron while battling COVID-19 earlier this month. He’s personally endorsed approving the treatments for emergency use, which would make them more widely available.
“I know people call it a therapeutic, but to me it’s a cure,” Trump told Fox News on Sunday, referring to the Regeneron treatment.
Both Regeneron and Eli Lilly asked the US Food and Drug Administration last week to issue emergency use authorizations for their antibody treatments. It’s uncertain when those approvals might arrive, but Trump has suggested they will come “very soon.”
AstraZeneca shares were up 0.8 percent in premarket trading Monday at $55.18 as of 7:35 a.m.