A replacement for a key COVID-19 antibody drug that has been used to protect immunocompromised Americans could be available within months, executives for drugmaker AstraZeneca said Thursday, after promising early results suggested it may work against “all known variants of concern” to date.
The company’s new experimental drug, currently named AZD3152, is being tested in a trial dubbedwith the hope of preventing symptomatic infection in people with weakened immune systems. Results from that study are on track to be out by September, an AstraZeneca spokesperson confirmed to CBS News.
That could tee up a potential emergency use authorization from the Food and Drug Administration to make the drug available by the end of the year, when another fall and winter resurgence of COVID-19 is expected.
The company has alreadyearly promising data from lab research of the drug, testing it against current and previous strains of SARS-CoV-2.
“In vitro studies demonstrated that AZD3152 neutralizes all COVID-19 variants, including Arcturus, the latest variant of concern,” AstraZeneca’s Mene Pangalos told investors on anthis week.
AstraZeneca says the drug could benefit some 2% of the population who cannot mount an effective immune response from COVID-19 vaccines.
“We hope to make AZD3152 available as a new prophylactic treatment in the second half of this year,” said Pangalos.
“A matter of some urgency”
Federal officials have been voicing concern over the gap in options for immunocompromised Americans, even as the emergency phase of the pandemic subsides.
An onslaught of immune-evasive Omicron variants over the past year has in part limited thefor treatment and prevention of Covid-19 for these more vulnerable patients.
AZD3152 relies on some of the same technologies that undergirded its predecessor Evusheld, which had also been authorized with the hope of shielding immunocompromised Americans from infection.
The FDAthat prophylactic drug’s emergency use authorization in January, citing the growing prevalence of variants that it would not work against.
AstraZeneca says its new AZD3152 drug is based on a different antibody – derived from donated B cells of people who have recovered from infections – and it is “designed to have broader variant coverage” than Evusheld for six months.
Immunocompromised patients who do end up getting infectedwith COVID-19 antiviral drugs, like Pfizer’s Paxlovid or Gilead’s Veklury treatments. However, these drugs can sometimes lead to the virus only being suppressed – but not eliminated – in immunocompromised patients.
“There are successors to the monoclonals that are in the process of being updated so that they will get the next generation of variants. And I expect, again, we’ll hear more about those in the coming few months,” the FDA’s Peter Marks said last month at ahosted by the National Foundation for Infectious Diseases.
Other options that might benefit people with weakened immune systems, like GSK’s monoclonal antibody treatment sotrovimab, haveby new Omicron strains.
“Obviously, there is a matter of some urgency there because, for immunocompromised individuals, it would be nice to have something,” said Marks.
The Biden administration has blamed a lack of funding from Congress for hobbling production of new antibody drugs for COVID-19, though a new infusion of some federal funding is now planned.
“I think we’ve been very clear that we’re running out of COVID dollars. We have indicated that over and over again, but we didn’t have the winter surge we expected, and we had additional funds,” Assistant Secretary for Preparedness and Response Dawn O’Connell told a Houselast week.
Federal officials recently announced they had been able to free up $5 billion for a “Project NextGen” effort to subsidize new vaccines and antibody drugs.
“We think creating the next generation of tools to protect Americans from COVID is a reasonable use of these next dollars,” said O’Connell.