Eli Lilly (LLY.US) and Incyte (INCY.US) Announce Baricitinib–Remdesivir Combination Therapy Significantly Shortens Recovery Time in COVID-19 Patients in ACTT-2 Phase 3 Trial
Eli Lilly
Global Pharmaceutical R&D and Production Company
Incyte
Small Molecule Drug Developer
National Institute of Allergy and Infectious Diseases
The National Institute of Allergy and Infectious Diseases (NIAID) is one of the 27 institutes and centers that constitute the National Institutes of Health (NIH), an agency within the U.S. Department of Health and Human Services. NIAID’s mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases. NIAID operates “intramural” laboratories in Maryland and Montana and funds research conducted by scientists at institutions across the United States and around the world.
FDA
U.S. Food and Drug Administration
Eli Lilly (LLY.US)andIncyte Corporation (INCY.US)The company announced that its JAK inhibitor baricitinib, in combination with remdesivir, met the primary endpoint in the adaptive Phase 3 ACTT-2 clinical trial sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID). Compared with remdesivir alone, the combination of baricitinib and remdesivir shortened patients’ recovery time.
Baricitinib, marketed under the brand name Olumiant, is a once-daily oral JAK1/2 inhibitor that has received FDA approval for the treatment of patients with moderate to severe rheumatoid arthritis. JAK1/2 proteins mediate various inflammatory responses. Inhibition of JAK1/2 may reduce the excessive inflammatory response caused by cytokine storm in patients with COVID-19.
Researchers observed that the median time to recovery was approximately one day shorter in patients receiving baricitinib in combination with remdesivir than in those receiving remdesivir alone. This finding was statistically significant.
Additional analyses of the clinical trial data, including mortality and safety data, are currently underway. NIAID expects to publish the full details of this study in a peer-reviewed journal.
Patrik Jonsson, Senior Vice President of Eli Lilly and President of Eli Lilly Bio-Medicines, stated, “We are satisfied with these data from the ACTT-2 study. We will continue to collaborate with NIAID to further understand these data and the role of baricitinib in future studies.”
Based on the ACTT-2 data, Eli Lilly plans to discuss with the U.S. FDA the possibility of obtaining Emergency Use Authorization (EUA).