Eli Lilly & Company (LLY - Free Report) and partner Incyte (INCY - Free Report) announced that a phase III study evaluating their rheumatoid arthritis drug, Olumiant (baricitinib) in combination with Gilead’s (GILD) remdesivir for hospitalized patients with COVID-19 infections met the primary endpoint of reduction of time to recovery in comparison with remdesivir.
The ACTT-2 study is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and included more than 1,000 patients. An approximate one-day reduction in median recovery time was observed for the overall patient population treated with Olumiant (4-mg dose) plus remdesivir compared to the remdesivir arm. The recovery time means how soon the participant is well enough for hospital discharge. This means the participant no longer requires supplemental oxygen or ongoing medical care in the hospital. Additional analyses of the data is ongoing to understand other clinical outcomes data.
Lilly is conducting a separate phase III study in the United States, Europe, Asia and Latin America to evaluate Olumiant, a JAK1/JAK2 inhibitor, as a potential treatment for hospitalized patients diagnosed with COVID-19. Based on data from the ACTT-2 study, Lilly will consider seeking emergency use authorization (EUA) from the FDA. It will propose that Olumiant be sold "through commercial channels” for COVID-19, if the FDA grants EUA. Please note that remdesivir is presently approved for emergency use by the FDA to treat all hospitalized patients with COVID-19
Lilly’s stock has risen 13.4% this year so far against a decrease of 0.1% for the industry.
Lilly is making rigorous efforts to make medicines/antibodies to treat COVID-19. It is developing an antibody therapy candidate, LYCoV555 in collaboration with AbCellera. The company has completed dosing of a phase I study and has initiated a phase II study on the candidate in people recently diagnosed with COVID-19 in the ambulatory setting. It is also conducting a separate phase III study on LYCoV555 for the prevention of COVID-19 at nursing homes
Lilly also has a separate collaboration with China-based Junshi Biosciences to co-develop therapeutic antibodies for COVID-19. The companies have completed dosing in a phase I study on LY-CoV016, the lead antibody from the collaboration.
Lilly is also conducting a phase II study of an antibody that targets Angiopoietin 2, which has been observed to be elevated in COVID-19 patients with acute respiratory distress syndrome or ARDS.
Several other companies are also working on developing new antibodies to combat the disease.
Vir Biotechnology’s (VIR - Free Report) investigational monoclonal antibody, VIR-7831 entered phase II/III study in August for the early treatment of COVID-19 in patients who are at high risk of hospitalization. A phase II study on another monoclonal antibody, VIR-7832 is expected to begin later this month. Regeneron’s (REGN - Free Report) , REGN-COV2, a novel investigational antibody "cocktail" treatment, is currently being studied in two phase II/III clinical studies for the treatment of COVID-19.
Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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