- Treatment with GlaxoSmithKline and Vir Biotechnology's antibody drug dramatically cut the risk of hospitalization or death due to COVID-19, final results from a large study show, confirming earlier findings and boosting the companies' case for the third-to-market therapy.
- At Day 29 of the study, the risk of hospitalization for more than 24 hours, or death from any cause, was 79% lower among people with mild-to-moderate COVID-19 treated with GSK and Vir's drug than among those given placebo, the companies said in a statement Monday. The trial enrolled just over 1,000 non-hospitalized patients at high risk for severe disease.
- The Food and Drug Administration cleared GSK and Vir's antibody, called sotrovimab, in late May based on early data from the same study. The new data will support the companies' application for full U.S. approval.
Antibody drugs from Eli Lilly, Regeneron and, most recently, partners GSK and Vir have been so far underutilized, hamstrung by difficulties in administration and outpaced by widespread vaccination that's reduced the risk of COVID-19 for tens of millions of Americans.
Nearly one million doses of monoclonal antibodies have been delivered to states through mid-June, according to a recent update from the Department of Health and Human Services shared by a New York Times reporter. Only 54% of the doses distributed by June 2 have been used, highlighting the slow uptake of the drugs.
But for people who do get COVID-19, monoclonal antibodies can be powerfully effective at forestalling the diseases' worst outcomes.
In GSK and Vir's study, only six participants who were treated with the companies' drug were hospitalized for more than 24 hours or died, the study's primary endpoint, compared with 30 participants who received placebo. Three of the six treated patients may have been hospitalized for reasons other than COVID-19, GSK and Vir said, citing small bowel obstruction, lung cancer and diabetic foot ulcer.
The 79% reduction in relative risk cited by GSK and Vir is slightly lower, but roughly comparable to the 85% figure the companies reported in a March interim analysis of 583 study participants.
Importantly, there were no "treatment-emergent" side effects reported at a higher rather with sotrovimab than with placebo. Rash and diarrhea were the most common adverse events in the group receiving the drug, but at low rates of only 1% and 2%, respectively.
Since sotrovimab's authorization May 27, the National Institutes of Health has added the drug to its treatment guidelines, alongside combination antibody regimens from Regeneron and Eli Lilly. Use of a single antibody drug from Lilly was stopped earlier this year after evidence indicated coronavirus variants could evade treatment, a problem that's affected use of the Indianapolis drugmaker's combination too.
Sotrovimab binds to a location on the coronavirus' spike protein that doesn't overlap with mutations observed in the virus variants, and testing in laboratories has shown the drug retains neutralizing activity against the variants Alpha, Beta, Gamma, Epsilon and Iota.
Clinical trial results have up until now only supported use of antibody drugs in the outpatient setting, before COVID-19 patients are sick enough to need hospitalization. But in a major finding earlier this month, data from the U.K. study RECOVERY showed Regeneron's combination cut the risk of death among hospitalized patients, too.
GSK and Vir have 450,00 doses of their drug on hand and expect to be able to manufacture 2 million doses in the first year following the May 27 authorization.
The companies are also studying an intramuscular dosing of the drug, which could make treatment more convenient than the intravenous infusion currently used.