- Vir Biotechnology and GlaxoSmithKline on Tuesday said they will begin the Phase 3 portion of clinical testing for their experimental coronavirus antibody drug following positive safety data from the initial part of the study.
- Vir and GSK skipped over the usual small Phase 1 safety studies and pushed straight into a mid-stage trial with a plan to expand the test rapidly if the antibody drug was judged to be safe. They will now test whether the drug can prevent COVID-19 from worsening in patients who have been diagnosed with a symptomatic infection. Interim results are expected by the end of the year.
- Coronavirus antibody drugs gained national notoriety last week when an experimental treatment from Regeneron was used to treat President Donald Trump. With wide-scale use of a coronavirus vaccine still months away, antibodies are seen as a potential "bridge" that could help keep more people from dying or needing invasive hospital care in the meantime.
Following President Trump's case, some now expect Regeneron's experimental antibody drug to soon receive emergency use authorization from the Food and Drug Administration. If so, Regeneron could be the first of several developers, including partners Vir and GSK, to seek permission for use of their drugs in the coming months.
Data generated to date by Regeneron and Eli Lilly, another antibody drug developer, are limited. But the companies have each shown at least some evidence their drugs may help certain patients with COVID-19. Vir and GSK haven't, but they could quickly make progress given their fast pivot into late-stage testing.
The two companies plan to enroll around 1,300 non-hospitalized patients with a COVID-19 diagnosis in the Phase 3 portion of the COMET-ICE trial, as it is known. Half would get the Vir and GSK drug, while the other half would receive placebo. The goal is to assess whether the antibody can keep patients alive and out of the hospital more effectively than placebo over the course of four weeks.
The partners said the decision to progress to the placebo-controlled efficacy trial was based on a 14-day "lead-in" portion of the trial, which evaluated the safety of their drug in 20 patients. The trial began on Aug. 31, and an independent data monitoring committee reviewed the results on Sept. 30. Vir and GSK have been cleared to move forward, but did not disclose specific findings on Tuesday.
The data monitoring committee will also conduct interim checks of the Phase 3 trial to see whether the study is likely to succeed, and to watch for any worrisome safety signal. Data could be available by the end of 2020, according to Vir and GSK, and the final analysis could occur in January.
Unlike vaccines, which stimulate the production of antibodies and immune-fighting blood cells, Vir's drug and other experimental antibody treatments are synthetic molecules infused into patients with the aim of neutralizing SARS-CoV-2. As such, they are most likely to be used in patients with a positive virus test or diagnosis of COVID-19, but won't stop the spread of disease as a vaccine might.
Regeneron's treatment consists of two antibodies given together, a feature designed to prevent the coronavirus from mutating to escape treatment and to account for genetic variations in the virus itself. Vir, by contrast, is using a single engineered antibody that's been modified to help its effects last longer.
Geoffrey Porges, an analyst at SVB Leerink, anticipates an emergency use authorization will come quickly for Regeneron's drug, writing in an Oct. 6 note to clients that the company could earn sales of at least $1 billion in 2021.