In the search for better therapeutic Covid-19, GlaxoSmithKline and Vir have partnered on two antibodies that hope to have a chance. GSK is also testing its own internal antibody, and early results may have closed the door on widespread use.
A combination of monoclonal antibody otilimab GSK plus standard treatment could not improve standard treatment alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study released Thursday .
The addition of otilimab resulted in only a 5.3% difference in clinical outcomes for patients treated with standard treatment, not enough to achieve statistical significance. It is not clear, however, how much GSK missed the target in the study of 806 patients because the drugmaker did not disclose a p-value.
But it is not necessarily the end of the game for optimum. In a pre-specified analysis, 65.1% of otilimab patients over 70 years of age were alive and did not have respiratory failure at the 28-day mark, compared with 45.9% of patients in the standard treatment arm. This resulted in a p value of 0.0009, well within the range of statistical significance. Meanwhile, at the 60-day mark, 26% of patients 70 years of age or older on the otilimab arm died compared to 40.4% on standard treatment alone. This difference only creaked below the significance mark at p = 0.04.
With some promise in this high-risk cohort, GSK will expand its 70-year-old or older cohort in the OSCAR study to 350 patients to determine whether to continue with otilimab in patients hospitalized in a Phase III trial.
Chris Corsico“Given the profound impact this pandemic is having on the elderly and the encouraging data we are sharing today, we hope that this discovery will be replicated in the additional cohort,” said Chris Corsico, senior vice president of development at GSK, in a communicated.
GSK hopes that its mixed results for otilimab, a granulocyte-macrophage colony-stimulating factor antibody, will not be replicated in the more advanced antibody that is undergoing Phase III tests with partner Vir Biotechnology.
In December, NIH announced that it would test the GSK and Vir candidate named VIR-7831, as well as a combination of Brii Biosciences antibodies in an initial population of 450 moderately ill Covid-19 patients over five days. After five days, the conditions of these patients will be assessed on two ordinal scales of seven points; then, based on the safety and effectiveness of both candidates, 1,050 additional patients would be included in a second phase of the study, some of whom may have severe illness. The study will assess the ability of both drugs to induce sustained recovery, as assessed by a hospital discharge and patients who live 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.
NIH took over the GSK and Vir antibody shortly after deciding to discard the injection of LY-CoV555 in the ACTIV-3 study, after finding little clinical efficacy. At the time, Lilly forwarded the theory that patients in the NIH study may have shown little effect on LY-CoV555 because they had been infected for a longer period and had received standard treatment, as well as remitting from Gilead before treatment.
The GSK-Vir pair also features a second partner antibody – VIR-7832 – which they announced in January that they would enter a Phase Ia / IIB study for hospitalized patients and those in the early stage of the disease. The partners think they may have a winner there, saying their newest antibody showed an “enhanced ability to clean infected cells and the potential to improve the function of virus-specific T cells, which could help treat and / or prevent infection. by COVID-19 “.
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