GSK’s Phase II otilimab study on COVID-19 patients promising for over-70s
GlaxoSmithKline’s (GSK) Phase II OSCAR study of their otilimab antibody’s effect on COVID-19 patients has shown promising results in older people, the company announced yesterday.
The trial measured the proportion of COVID-19 patients who were alive and free of respiratory failure 28 days after treatment, with a single dose of otilimab in addition to standard care, compared to patients treated with just standard care. The data showed a statistically insignificant difference of just 5.3%.
However, the trial did show significance in patients over 70 years of age. In this age group, 65.1% were alive and free of respiratory failure 28 days after receiving otilimab, compared to 45.9% on standard care only.
When expanding the trial to day 60, a treatment difference of 14.4% was still shown in these patients.
As a result of the findings, GSK has decided to amend the OSCAR study to expand the cohort of over-70s to confirm these potentially significant results. The original trial studied 809 patients between 18 and 79 years old, whereas the additional cohort will enrol approximately 350 patients aged 70 and older.
Recent research has suggested the role of the cytokine GM-CSF in the immune response to COVID-19 may be more prominent in patients over 70, putting them at an increased risk of serious complications related to the virus.
Christopher Corsico, Senior Vice President of Development at GSK, said: “Patients aged 70 and over account for 70% of COVID-related deaths and nearly 40% of hospitalisations. Our scientific understanding of COVID continues to evolve at a rapid pace with recent studies suggesting that GM-CSF is elevated in this group of patients.
“Given the profound impact this pandemic is having on the elderly and the encouraging data we are sharing today, we are hopeful this finding will be replicated in the additional cohort.”
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