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GGSK/Vir antibody drug Sotrovimab for early treatment of COVID-19
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GSK/Vir antibody drug Sotrovimab for early treatment of COVID-19.
GSK/Vir antibody drug Sotrovimab: The effect of intramuscular injection is comparable to that of intravenous infusion, which can simplify the way of administration!
Sotrovimab has been authorized to treat mild to moderate high-risk adults and adolescents infected with COVID-19. Intramuscular injection will provide patients with a more convenient drug delivery option.
Image source: pharmaintelligence.informa.com
Recently, GlaxoSmithKline (GSK) and Vir Biotech jointly released top-line data from a randomized multi-center open-label Phase 3 COMET-TAIL trial. The trial recruited trial participants during the Delta variant pandemic in the United States. The trial reached the primary endpoint.
The data confirms that it is used for high-risk, non-hospitalized adults and adolescents (≥12 years old) with mild to moderate COVID-19 In the early treatment of patients, Sotrovimab intramuscular injection (IM) is not inferior to intravenous infusion (IV), and the efficacy of the two methods of administration is similar.
The COMET-TAIL trial aims to evaluate the efficacy, safety, and tolerability of Sotrovimab treatment (IM, IV) administered in two ways in high-risk patients within 7 days after the onset of symptoms.
During the 29 days of the trial, 2.7% of the patients in the IM administration group (500mg) progressed to hospitalization for more than 24 hours or died, and the IV administration group (500mg) was 1.3%, and the adjusted difference between the two groups was 1.07% ( 95%CI: -1.25% to 3.39%).
The upper limit of 95% CI is within 3.5% of the default non-inferiority threshold for the primary endpoint of the trial, negotiated with the US FDA . In addition, the incidence of serious adverse events and grade 3-4 adverse events is low (1% in both groups of the 2 indicators).
GSK and Vir plan to advance regulatory submissions globally, including discussions with the FDA on the existing emergency use authorization (EUA) of Sotrovimab. Sotrovimab is a single-dose SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (age ≥ 12 years old, weight ≥ 40 kg) who do not require oxygen supplementation and are at risk of developing severe COVID-19.
In June of this year, GSK and Vir announced the complete results of the third phase of the COMET-ICE trial. The trial was carried out in non-hospitalized patients with mild to moderate COVID-19 who are at high risk of developing a serious disease , and evaluated the efficacy and safety of Sotrovimab intravenous (IV) therapy.
The trial reached the primary endpoint: within 29 days, compared with placebo, single-dose Sotrovimab IV treatment resulted in a 79% reduction in the number of patients hospitalized for more than 24 hours or died from any cause (adjusted relative risk reduction; p<0.001 ) .
Dr. Hal Barron, Chief Scientific Officer and President of GSK, said: “I am very pleased that today’s results show that compared with intravenous injection, direct intramuscular injection of Sotrovimab has a similar effect, which will provide patients with more convenient dosing options. We look forward to it. Work with regulatory agencies to help eligible COVID-19 patients use this new option.”
Dr. George Scangos, Chief Executive Officer of Vir, said: “This trial was conducted during a period of high prevalence of the Delta variant, and a large number of patients were enrolled in Florida, USA-this is the hot spot for the Delta variant, and the hospitalization rate On average, more than 10% of confirmed cases. We designed Sotrovimab to resist the mutations we expected to occur.
The data released this time show that after approval, Sotrovimab administered by intravenous or intramuscular injection is expected to be effective in fighting COVID-19 Play an important role. As the third year of the pandemic is approaching, we expect to continue to require multiple treatment options, especially for high-risk patients with complex health needs.”
Sotrovimab is a monoclonal antibody with dual functions, and has the potential to block the virus from entering healthy cells and eliminate infected cells. Sotrovimab can bind to an epitope shared by SARS-CoV-2 and SARS-CoV-1 (the virus that causes SARS).
This epitope is highly conserved, which may make resistance development more difficult. Sotrovimab incorporates Xencor’s Xtend technology and is also designed to achieve high concentrations in the lungs to ensure optimal penetration of the airway tissues affected by SARS-CoV-2 and have an extended half-life . Sotrovimab targets a conserved epitope of the S protein that is unlikely to mutate over time.
In vitro experimental data show that Sotrovimab is active against all known related variants. This shows that Sotrovimab has the potential to become an important new treatment option to fight the current pandemic and future coronavirus outbreaks.
At the end of May this year, the US FDA granted Sotrovimab emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 adult and pediatric patients (12 years and older, weighing at least 40 kg) with high risk, specifically: Patients who have tested positive for the direct SARS-CoV-2 virus and are at high risk of developing severe COVID-19 (including hospitalization and death).
In addition, Sotrovimab has obtained positive scientific opinions from the European Commission for Medicinal Products for Human Use (CHMP) recommending the granting of temporary marketing authorization. Currently, Sotrovimab has also been granted temporary licenses in many countries around the world.
Recognizing the urgency of the needs of patients around the world, GSK and Vir are working with governments and procurement agencies to provide Sotrovimab to support the response to the COVID-19 pandemic.
GSK and Vir have signed supply agreements with many governments around the world, and will continue to work hard as the epidemic continues to develop.
GSK and Vir are committed to continuous evaluation of Sotrovimab, because the COVID-19 pattern continues to develop at different rates on a global scale, and new variants have emerged. In vitro research data published in bioRxiv confirms that Sotrovimab maintains activity against popular variants of interest, including but not limited to Delta (B.1.6172), Delta+ (AY.1 or AY.2) and Mu(B .1.621).
Primary endpoint met in COMET-TAIL Phase III trial evaluating intramuscular administration of Sotrovimab for early treatment of COVID-19
GSK/Vir antibody drug Sotrovimab for early treatment of COVID-19
(source:internet, reference only)