A Phase III trial of Eli Lilly and Incyte's baricitinib has failed to meet its primary endpoint in patients hospitalised with COVID-19.
Baricitinib-treated patients were just 2.7% less likely than those receiving standard of care (SoC) to progress to ventilation (non-invasive or mechanical) or death by day 28, a difference that was not statistically significant.
In the COV-BARRIER trial, treatment with baricitinib in addition to SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) did however result in a significant reduction in death from any cause by 38% by day 28.
A numerical reduction in mortality was observed for all baseline severity subgroups of baricitinib-treated patients and was most pronounced for patients receiving non-invasive mechanical ventilation at baseline (17.5% versus 29.4% for baricitinib plus SoC versus SoC). Also, a reduction in mortality was also seen for the pre-specified subgroups of patients being treated with or without corticosteroids at baseline.
"Even though the study did not show a statistically-significant benefit on the primary endpoint, this trial showed the largest effect reported to date for reduction in mortality observed for this patient population with COVID-19,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines.
“As there remains an urgent need to reduce COVID-related deaths in hospitalised patients, we hope these results will provide further understanding and support for baricitinib's potential role in treatment on top of the current standard of care."
Lilly said it will share data from COV-BARRIER with regulatory authorities in the US, EU and other geographies to assess next steps for baricitinib for the treatment of hospitalised COVID-19 patients.