GSK, after pushing past midphase fail, ends development of otilimab in COVID-19

GlaxoSmithKline is stopping development of otilimab in COVID-19, reacting to the failure of the drug in phase 2 and the progress of its anti-SARS-CoV-2 antibody by pulling the plug on the program. Development of otilimab in rheumatoid arthritis is continuing. 

In February, GSK revealed a single dose of otilimab failed to improve the likelihood of being alive and free of respiratory failure 28 days later in patients with severe COVID-19-related pulmonary disease. However, a preplanned analysis of 180 people aged 70 years and older offered encouragement, with 65.1% of patients on otilimab meeting the endpoint criteria compared to 45.9% of their counterparts in the control group. GSK also saw a difference in the mortality rate.

Encouraged by the signs of efficacy, GSK outlined plans to enroll another 350 seniors to validate the effect of otilimab in the population and completed the study over the summer. While GSK is yet to share data from the extension, it has concluded that the overall picture in the pandemic and its COVID-19 portfolio doesn’t support further work on otilimab in the indication. 

“The increasing evidence that Xevudy plays an important role as a treatment for mild-to-moderate COVID-19 in high-risk adult and paediatric patients and the decision to generate more data on this medicine given the continued evolution of the pandemic, has led to the decision not to further explore otilimab as a potential treatment for severe pulmonary COVID-19 related disease in patients 70 years and older,” GSK wrote (PDF) in its third-quarter results.

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Xevudy is the anti-SARS-CoV-2 antibody GSK is developing with Vir Biotechnology. The antibody, also known as sotrovimab, now has emergency authorizations in markets including the U.S. and is covered by binding agreements for the sale of more than 420,000 doses.

Otilimab could have covered a different set of COVID-19 patients, with GSK targeting people who required significant oxygen support or early invasive mechanical ventilation. The enrollment criteria reflected evidence that the GM-CSF cytokine is implicated in the deterioration of patients, leading GSK to identify its anti-GM-CSF antibody otilimab as a potential treatment.

While GSK is stopping work on COVID-19, it is continuing to study otilimab in rheumatoid arthritis. A phase 3 clinical trial in the indication is continuing and scheduled to deliver data in the second half of next year.