Sotrovimab Intramuscular Injection Demonstrates Non-Inferior Efficacy to IV Infusion in Early Treatment of High-Risk COVID-19 Patients, Offering Simplified Administration

November 15, 2021 /BioValleyBIOON/ -- According to Baidu's "Real-time Updates on the COVID-19 Pandemic"Big DataReport》，As of 01:00 on November 15, 2021, the global cumulativeMore than 250 million confirmed cases (253.87 million), and over 5.11 million deaths。

Recently,GSK(GSK) and Vir Biotechnology, Inc. jointly announced the topline data from the randomized, multi-center, open-label Phase 3 COMET-TAIL trial. The trial enrolled participants during the period when the Delta variant was prevalent in the United States, and it achieved the primary endpoint, with data confirming:For the early treatment of mild to moderate COVID-19 in high-risk, non-hospitalized adults and adolescents (≥12 years), sotrovimab intramuscular (IM) injection is non-inferior to intravenous infusion (IV), with similar efficacy for both administration methods.

The COMET-TAIL trial aims to evaluate the efficacy, safety, and tolerability of sotrovimab administered via two methods (IM, IV) within 7 days of symptom onset in high-risk patients.During the 29-day trial, 2.7% of patients in the IM administration group (500mg) progressed to hospitalization for more than 24 hours or death, compared to 1.3% in the IV administration group (500mg), with an adjusted difference of 1.07% between the two groups.(95% CI: -1.25% to 3.39%). The upper limit of the 95% CI is associated with the United States.FDAThe pre-specified non-inferiority margin for the primary endpoint of the trial, as agreed upon through consultation, was within 3.5%. Additionally, the incidence rates of severe adverse events and grade 3-4 adverse events were low (for both metrics, 1% in each group).

GSK and Vir plan to advance regulatory submissions globally, including withFDADiscussion on the existing Emergency Use Authorization (EUA) for sotrovimab.Sotrovimab is a single-dose SARS-CoV-2 monoclonal antibody used to treat adults and adolescents (aged ≥12 years, weighing ≥40 kg) who do not require supplemental oxygen and are at risk of progressing to severe COVID-19.

In June this year, GSK and Vir announced the full results of the Phase 3 COMET-ICE trial. The trial wasIn non-hospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe diseaseInitiated, the efficacy and safety of intravenous (IV) infusion of sotrovimab were evaluated. The trial met its primary endpoint: within 29 days,Compared with placebo, a single dose of sotrovimab IV treatment reduced the number of patients hospitalized for more than 24 hours or died for any reason by 79% (adjusted relative risk reduction; p<0.001).。

GSK Chief Scientific Officer and President Dr. Hal Barron said, "I am pleased that today's results show that intramuscular administration of sotrovimab has similar efficacy compared to intravenous infusion, which will provide patients with a more convenient treatment option. We look forward to working with regulatory authorities to make this new option available to eligible COVID-19 patients."

Vir CEO Dr. George Scangos stated, "This trial was conducted during a period when the Delta variant was highly prevalent, with a significant number of patients enrolled in Florida, USA—a hotspot for the Delta variant where hospitalization rates exceeded 10% of confirmed cases on average. We designed sotrovimab to withstand the variants we anticipated would emerge. The data released today suggest that sotrovimab, administered via intravenous infusion or intramuscular injection, is expected to play a crucial role in combating COVID-19 after receiving approval. As we approach the third year of the pandemic, we anticipate a continued need for multiple treatment options, especially for high-risk patients with complex health needs."

Sotrovimab is a monoclonal antibody with dual action, having the potential to both block the virus from entering healthy cells and clear infected cells.Sotrovimab is able to bind to an epitope shared by SARS-CoV-2 and SARS-CoV-1 (the virus that causes SARS), which is highly conserved, potentially making the development of resistance more difficult. Sotrovimab incorporates Xencor's Xtend technology and is also designedTo achieve high concentrations in the lungs, ensuring optimal penetration of the airway tissues affected by SARS-CoV-2, with 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 relevant variants. This suggests that sotrovimab has the potential to be an important new treatment option for combating the current pandemic and future coronavirus outbreaks.

At the end of May this year, the United StatesFDASotrovimab has been granted Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older, weighing at least 40 kg) who are at high risk of progressing to severe COVID-19 (including hospitalization and death), specifically those with positive results from direct SARS-CoV-2 viral testing. Additionally, sotrovimab has received a positive scientific opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending the granting of interim marketing authorization. Sotrovimab has also been granted provisional authorization in multiple countries worldwide.

In recognition of the urgent needs of patients around the world, GSK and Vir are collaborating with governments and procurement organizations to provide sotrovimab in support of the response to the COVID-19 pandemic. GSK and Vir have signed supply agreements with multiple governments worldwide and will continue their efforts as the pandemic evolves.

GSK and Vir Biotechnology are committed to the ongoing evaluation of sotrovimab, as the landscape of COVID-19 continues to evolve at different rates globally, with new variants emerging. In vitro study data published on bioRxiv confirm that sotrovimab retains activity against prevalent variants of concern, including but not limited to Delta (B.1.6172), Delta+ (AY.1 or AY.2), and Mu (B.1.621). (Bioon.com)

Source of the original text:Primary endpoint met in COMET-TAIL Phase III trial evaluating intramuscular administration of sotrovimab for early treatment of COVID-19