(RTTNews) - GlaxoSmithKline (GSK.L, GSK) said that a phase 2 clinical trial of its otilimab in hospitalized COVID-19 patients did not reach statistical significance.
However, a pre-planned efficacy analysis by age in patients 70 years and older showed that 65.1% of patients were alive and free of respiratory failure 28 days after treatment with otilimab plus standard of care, compared to 45.9% of patients who received the standard of care alone.
GSK said it has decided to amend the OSCAR study to expand this cohort to confirm these potentially significant findings.
Otilimab is an investigational anti-granulocyte macrophage colony-stimulating factor (anti-GM-CSF) monoclonal antibody.
The primary endpoint of the OSCAR study was 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 of care (including anti-viral treatments and corticosteroids), compared to patients being treated with standard of care alone.
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