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GlaxoSmithKline To Amend Covid-19 Treatment Study To Confirm Findings

Thu, 25th Feb 2021 12:23

(Alliance News) - GlaxoSmithKline PLC on Thursday reported results from the phase 2 proof-of-concept Oscar study with otilimab, an investigational anti-granulocyte macrophage colony-stimulating factor monoclonal antibody.

Oscar stands for otilimab in severe Covid-19 related disease.

The Brentford, England-based pharmaceutical company said 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, compared to patients being treated with standard of care alone.

Data from patients of all ages showed a treatment difference of 5.3% but this did not reach statistical significance, GSK noted.

However, a pre-planned efficacy analysis by age in patients 70 years and older showed that 65% of patients were alive and free of respiratory failure 28 days after treatment with otilimab plus standard of care, compared to 46% of patients who received the standard of care alone.

Given these data suggest a potentially important clinical benefit in a pre-defined sub-group of high-risk patients, GSK said it has decided to amend the Oscar study to expand this cohort to confirm these potentially significant findings.

"Patients aged 70 and over account for 70% of Covid-related deaths and nearly 40% of hospitalisations," said Christopher Corsico, senior vice president of Development at GSK.

"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," added Corsico.

GlaxoSmithKline shares were trading marginally higher in London on Thursday at 1,213.00 pence each.

By Evelina Grecenko; evelinagrecenko@alliancenews.com

Copyright 2021 Alliance News Limited. All Rights Reserved.

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