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In the search for a better Covid-19 treatment, GlaxoSmithKline and Vir have teamed up on two antibodies they hope will stand a chance. GSK is also testing its own internal antibody, and early results may have closed the door to its widespread use.
According to data from the Phase IIa OSCAR study released Thursday, a combination of GSK’s otilimab monoclonal antibody and standard of care may not be the best standard of care on its own to prevent death and failure. respiratory in hospitalized Covid-19 patients after 28 days.
The addition of otilimab resulted in only a 5.3% difference in clinical outcome between patients treated with standard care, which is not sufficient to achieve statistical significance. However, it is not known how far GSK missed the mark in the study of 806 patients because the drug maker did not release a p-value.
But it is not necessarily over for otilimab. In a pre-specified analysis, 65.1% of otilimab patients over 70 years of age were alive and had no respiratory failure at 28 days, compared to 45.9% of patients in the standard care arm . This gave a p-value of 0.0009, well within the range of statistical significance. Meanwhile, at 60 days, 26% of patients 70 years and older in the otilimab arm had died, compared to 40.4% with standard care alone. This difference just squeaked under the significance mark at p = 0.04.
With some promise in this high-risk cohort, GSK will expand its 70+ cohort in the OSCAR study to 350 patients to determine whether it will continue otilimab in hospitalized patients as part of a drug test. phase III.
Chris Corsico“Given the profound impact of this pandemic on the elderly and the encouraging data that we share today, we hope this finding will be replicated in the additional cohort,” said Chris Corsico, senior vice president of development from GSK, in a press release.
GSK is hoping that its very mixed results for otilimab, a granulocyte and macrophage colony stimulating factor antibody, will not be replicated in the more advanced antibody it is crossing in phase III trials with its partner Vir Biotechnology.
In December, the NIH announced it would test the candidate from GSK and Vir, dubbed VIR-7831, as well as an antibody combo from Brii Biosciences in an initial population of 450 moderately ill patients with Covid-19 over a period of time. of five days. After five days, the condition of these patients will be assessed on two ordinal seven-point scales; then, based on both the safety and efficacy of the candidates, an additional 1,050 patients would be added to a second phase of the study, some of whom may have serious illness. The study will assess the ability of the two drugs to induce a lasting cure, judged by hospital discharge and patients living at home for 14 days before a 90-day follow-up.
The first results of this study – the NIH ACTIV-3 “master protocol” – have not yet been reported.
The NIH attacked the GSK and Vir antibody shortly after deciding to discontinue the LY-CoV555 vaccine in the ACTIV-3 study after finding little clinical efficacy. At the time, Lilly forwarded the theory that patients in the NIH trial may have shown little effect on LY-CoV555 because they had already been infected for a longer time and received standard care as well as the remdesivir by Gilead before treatment.
The GSK-Vir pair also sport a second associated antibody – VIR-7832 – which they announced in January would enter a Phase Ia / IIB study for inpatients and those with early stage disease. The partners believe they might have a winner there, saying their latest antibody has shown “increased ability to clear infected cells and potential to improve the function of virus-specific T cells, which could help treat and / or prevent infection with COVID-19. “
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