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COVID-19 Treatment Did Not Meet Statistical Significance on Primary Endpoint

April 8, 2021 • 11:09 am CDT
(Precision Vaccinations)

Indianapolis-based Eli Lilly and Incyte announced COV-BARRIER results, a Phase 3 study evaluating baricitinib 4 mg once daily plus standard of care (SoC) versus placebo plus SoC, on April 8, 2021. 

The clinical trial did not meet statistical significance on the primary endpoint, which was defined 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 (ECMO) or death by Day 28.

Baricitinib-treated patients were 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 (odds ratio [OR]: 0.85; 95% CI 0.67, 1.08; p=0.1800).

Baricitinib has not been approved for the treatment of COVID-19 but has been authorized for emergency use by the U.S. FDA

"Since the beginning of the pandemic, we have worked to expand the science behind COVID-19 therapies," commented Ilya Yuffa, SVP, and president of Lilly Bio-Medicines, in a related press release.

"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 the reduction in mortality observed for this patient population with COVID-19."

"As there remains an urgent need to reduce COVID-related deaths in hospitalized 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 stated it intends to publish detailed results of this study in a peer-reviewed journal in the coming months. Lilly will share the data from COV-BARRIER with regulatory authorities in the U.S., European Union, and other geographies to evaluate the next steps for baricitinib for the treatment of hospitalized COVID-19 patients.

Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. It is approved and commercially available as OLUMIANT in the U.S. and more than 70 countries as a treatment for adults with moderate to severe active rheumatoid arthritis (RA) and in the European Union and Japan for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Baricitinib is authorized for use under an Emergency Use Authorization combined with remdesivir to treat suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older, requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Delaware-based Incyte is a global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development, and commercialization of proprietary therapeutics. 

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