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Lilly Announces Clinical Study Plans for Coronavirus Disease

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Eli Lilly (LLY - Free Report) signed an agreement with the National Institute of Allergy and Infectious Diseases (“NIAID”), part of the National Institutes of Health (“NIH”), to evaluate its JAK inhibitor, Olumiant (baricitinib), as a potential treatment for hospitalized patients diagnosed with COVID-19.

The drug will be evaluated in one of the arms of NIAID's Adaptive COVID-19 Treatment study. The evaluation of efficacy and safety of Olumiant in the above patient population will begin in the United States this month and will be later expanded to additional sites, including Europe and Asia. Data from the U.S. study site are expected in the next two months.

Notably, Olumiant is approved for treating moderately to severely active rheumatoid arthritis (“RA”). Several other RA drugs are also being evaluated as a treatment for COVID-19. These include Roche’s (RHHBY - Free Report) and Regeneron (REGN - Free Report) /Sanofi’s (SNY - Free Report) IL-6 receptor antagonists, Actemra and Kevzara, respectively. While Actemra is being evaluated for severe COVID-19 pneumonia, Kevzara is being evaluated in patients hospitalized with severe infection due to COVID-19.

It is being predicted that anti-inflammatory activities of RA drugs may have a potential beneficial effect on COVID-19 patients.

Apart from Olumiant, Lilly is planning to advance its selective monoclonal antibody against Angiopoietin 2 (Ang2) candidate, LY3127804, to a phase II study. The study will evaluate the candidate in pneumonia patients hospitalized with COVID-19 who are at a higher risk of progressing to acute respiratory distress syndrome. Ang2 is found in high levels in ARDS patients and the study will test if LY3127804 can inhibit the effects of Ang2 and reduce the progression to ARDS or the need for mechanical ventilation in COVID-19 patients. The study is expected to start later this month.

Lilly’s shares have increased 10.9% so far this year against the industry’s decline of 6.6%.

We note that Lilly collaborated with private biotech, AbCellera, last month to co-develop antibody therapies to treat and prevent COVID-19. The companies will select from more than 500 unique antibodies identified by AbCellera and isolated from the blood sample of a U.S. COVID-19 patient who recovered from the disease. The companies will equally share initial development costs for the antibody products, after which Lilly will take care of further development, manufacturing and distribution.

Many other large and small pharma/biotech companies are actively pursuing the development of a vaccine or treatment for COVID-19. Among the large players, J&J and Sanofi are planning to develop a vaccine, while Gilead’s antiviral candidate, remdesivir, is in late-stage development. Smaller biotechs, including Moderna and Novavax, are primarily focusing on developing vaccines for the deadly disease, which has infected more than 1.8 million people worldwide.

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Lilly currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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