Eli Lilly and Company LLY announced that it has initiated dosing in a phase I study, which will evaluate an antibody candidate, LY-CoV555, as a treatment for COVID-19. The candidate is the first to enter clinical study under the company’s collaboration with privately-held AbCellera. Lilly had signed a collaboration agreement with AbCellera in March 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 company believes the study to be the first clinical study to evaluate an antibody therapy for COVID-19. The therapy is specifically designed to attack SARS-CoV-2, the virus that causes COVID-19. Antibody therapies are believed to have potential for both prevention and treatment of COVID-19.
LY-CoV555 antibody was identified from a blood sample taken from an early COVID-19 patients who had recovered from the disease by AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) three months ago. Lilly plans to review data from this study later this month. The company intends to initiate broader efficacy studies, if the antibody candidate is found to be safe in the phase I study. The company also intends to develop other neutralizing antibodies against SARS-CoV-2 over the next several months as single antibody therapy as well as combinations of Lilly antibodies. Lilly is also beginning large-scale manufacturing of this potential therapy simultaneously with its R&D efforts
Notably, Lilly’s JAK inhibitor, Olumiant (baricitinib), is also being evaluated as a potential treatment for hospitalized patients diagnosed with COVID-19 in a study conducted by NIAID. Lilly is also evaluating its monoclonal antibody against Angiopoietin 2 (Ang2) candidate, LY3127804 in a phase II study in pneumonia patients hospitalized with COVID-19 who are at a higher risk of progressing to acute respiratory distress syndrome.
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 JNJ and Sanofi SNY are planning to develop a vaccine.Gilead’s GILD antiviral candidate, remdesivir, is in late-stage development.
Lilly’s shares have rallied 16% so far this year against the industry’s decline of 0.4%.
In a separate press release, Lilly announced that the FDA has approved a supplemental Biologics License Application (sBLA) seeking label expansion of its inflammatory drug, Taltz, as a treatment for active non-radiographic axial spondyloarthritis. With this approval, Taltz becamethe first-of-its-kind (IL-17A antagonist) to get approval in this indication.
This is the fourth FDA-approved indication for Taltz. The drug is also approved for treating plaque psoriasis, active psoriatic arthritis and active axial spondyloarthritis. With the approval Taltz is now approved to treat patients across the full axSpA spectrum, including ankylosing spondylitis (AS), also known as radiographic axSpA, and nr-axSpA.
The approval was based on data from the phase III study — COAST-X — which evaluated the drug for improvement in signs and symptoms of nr-axSpA. Data from the study had shown that treatment with Taltz led to improvement in 30% of nr-axSpA patients compared to 13% for placebo.
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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