Unknowingly, the COVID-19 epidemic is about to enter its third year. The harm caused by this global disaster is visible to the naked eye. From no cure to the fact that we can now be vaccinated against the COVID-19 vaccine or take the oral COVID-19 drug Molnupiravir to treat it, we have all witnessed our determination to fight the epidemic. Currently, more and more drugs to treat COVID-19 are being developed and some progress has been made.
On November 12, 2021, GlaxoSmithKline (GSK) and Vir Biotechnology (Vir) announced topline data from the randomized, multicenter, open-label, Phase 3 COMET-TAIL trial, which met its primary endpoint demonstrating that intramuscular (IM) sotrovimab is noninferior to intravenous (IV) in the early treatment of mild to moderate COVID-19 in high-risk, non-hospitalized adults and adolescents (12 years and older).
The Phase 3 COMET-TAIL trial was designed to compare the efficacy, safety and tolerability of sotrovimab administered intramuscularly versus intravenously within 7 days of symptom onset in high-risk patients. The progression rate to hospitalization for more than 24 hours or death by day 29 was 2.7% in the IM group (500mg) and 1.3% in the IV group (500mg). The adjusted difference between the IM and IV groups was 1.07%, with a 95% confidence interval (CI) of -1.25% to 3.39%. The upper limit of the 95% CI was within the predetermined 3.5% non-inferiority range for the trial's primary endpoint, determined in consultation with the FDA.
The companies plan to make regulatory filings globally, including ongoing discussions with the FDA regarding sotrovimab's existing emergency use authorization.
Vir CEO George Dr. Scangos said: "This trial was conducted during the peak of the spread of the Delta variant, with a large number of registrations in Florida (an area where the Delta variant is endemic) and an average hospitalization rate of more than 10% among confirmed cases. We designed sotrovimab to be resistant to the expected "As the pandemic approaches its third year, we continue to need multiple treatment options, especially for high-risk patients with complex health needs."
The results of the COMET-TAIL trial follow the announcement in the first half of 2021 of the phase 3 COMET-ICE trial, which studied intravenous infusion of sotrovimab in adult patients with mild or moderate COVID-19 who are at high risk of progression to severe disease. Final results from the COMET-ICE trial showed that among 1,057 subjects, sotrovimab reduced hospitalization and death rates at day 29 by 79% compared with placebo.
Sotrovimab is an investigational SARS-CoV-2 neutralizing monoclonal antibody. The antibody binds to an epitope on SARS-CoV-2 [shared with SARS-CoV-1 (the virus that causes SARS)], suggesting that the epitope is highly conserved, which may make it more difficult to develop resistance.
References:
https://us.gsk.com/en-us/media/press-releases/primary-endpoint-met-in-comet-tail-phase-iii-trial-evaluating-intramuscular-administration-of-sotrovimab-for-early-treatment-of-covid-19/
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