The British pharmaceutical company GlaxoSmithKline and the American biotechnology company Vir Biotechnology, which began their partnership a year ago in full pandemic to fight the virus, have announced the main data of the randomized, multicentre and open-label Phase III study COMET- TAIL, which met its primary endpoint, demonstrating that intramuscular administration of sotrovimab was non-inferior to intravenous administration for early treatment of mild to moderate COVID-19 in non-hospitalized, high-risk adults and adolescents of age or age. over 12 years. The trial took place during the Delta variant wave of the pandemic in the United States.
Covid drugs: Monoclonals against variants
by Letizia Gabaglio
Sotrovimab is a monoclonal antibody that acts against Sars-CoV-2, binds to an epitope (portion of an antigen bound by a specific antibody) stored on the spike protein of the same virus, and reduces its ability to penetrate into the cells of the virus. body.
The study was designed to evaluate the efficacy, safety and tolerability of the monoclonal antibody administered intramuscularly versus intravenous administration in high-risk patients for up to seven days after the onset of symptoms. The joint official statement from the two companies reads: “In the intramuscular (500 mg) arm of the study there was a 2.7% rate of progression to hospitalization for more than 24 hours or death to day 29 of the study, compared with 1.3% in the intravenous (500 mg) arm. The adjusted difference between the two study arms was 1.07%, with a 95% confidence interval ranging from – 1.25% and 3.39%. In addition, low rates of serious adverse events and grade 3-4 adverse events (less than or equal to 1% in both arms) were observed in the main data. “
Covid, over 12,000 patients treated with monoclonal drugs
The companies plan to pursue regulatory requests globally, including ongoing discussions with the Food and Drug Administrationin (FDA) regarding the existing emergency use authorization for sotrovimab.
Dr Hal Barron, Chief Scientific Officer and President, said: “I am delighted that today’s results have demonstrated similar efficacy for sotrovimab when injected directly into muscle compared to that given intravenously, potentially offering a more cost-effective option for patients. We look forward to working with regulatory authorities to help make this new option available to appropriate COVID-19 patients. “
George Scangos, Ph.D., chief executive officer of Vir, said, “This study was conducted during the peak of circulation of the Delta variant, with a significant enlistment in Florida, a hot spot for this particular variant and where the rates hospitalizations were on average more than 10% of confirmed cases. We designed sotrovimab to resist the variants we predicted would occur and these data show that sotrovimab administered intravenously or intramuscularly could prove important in the fight against COVID-19 after authorization”.
Pills and subcutaneous monoclonal antibodies: more and more treatments against Covid
by Irma D’Aria
Current data follow those from the first half of 2021, related to the phase III COMET-ICE study which investigated intravenous infusion of sotrovimab in adults with mild or moderate COVID-19 at high risk of progression to severe disease. The final results of the COMET-ICE study in the full study population of 1057 participants demonstrated a 79% reduction in hospital admissions and deaths on day 29 compared to placebo.
.