Lily and Incyte Phase III COVID-19 study fails to meet primary endpoint

pharmafile | April 9, 2021 | News story | Medical Communications COVID-19, Eli Lily 

Results from Eli Lily and Incyte’s Phase III study, COV-BARRIER, evaluating baricitinib in the treatment of hospitalised COVID-19 patients did not meet statistical significance on the primary endpoint.

The primary endpoint was defined in this study as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation, including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation, or death by day 28.

Baricitinib-treated patients were found to be 2.7% less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant.

The COV-BARRIER study did show a 38% significant reduction in mortality by day 28 in patients treated with baricitinib in addition to standard of care (SoC), which includes corticosteroids and remdesivir.

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.

Co-primary investigator E. Wesley Ely, MD, MPH, professor of medicine and co-director of the Critical Illness, Brain Dysfunction, and Survivorship Center at Vanderbilt University Medical Center, said: “There remains a driving unmet need for treatments with the potential to further decrease mortality for COVID-19 patients.

“While COV-BARRIER did not hit the primary endpoint based on stages of disease progression, the data show that baricitinib meaningfully reduced the risk of mortality above and beyond the recommended standard of care, without additional safety risks.

“These important findings advance our pursuit of treatment options to save lives in hospitalised COVID-19 patients.”

The frequency of adverse events and serious adverse events were generally similar in the baricitinib and placebo groups. Serious infections and venous thromboembolism occurred in 8.5% and 2.7% of patients treated with baricitinib, respectively, versus 9.8% and 2.5% of patients treated with placebo. No new safety signals potentially related to the use of baricitinib were identified.

Lilly intends to publish the results of the study in a peer-reviewed journal in the coming months. Lilly will also share the data from COV-BARRIER with regulatory authorities in the US, EU and other geographies, to evaluate next steps for baricitinib for the treatment of hospitalised COVID-19 patients.

Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines, said: “Since the beginning of the pandemic, we have worked to expand the science behind COVID-19 therapies.

“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.

“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.”

Kat Jenkins

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