Eli Lilly & Company LLY announced proof of concept data from the phase II study — BLAZE-1 — evaluating its antibody therapy candidate, LY-CoV555, to treat COVID-19. The company is developing the candidate in collaboration with privately-held Canada-based company, AbCellera.
The data was announced following an interim analysis of the study evaluating three doses —700 mg, 2800 mg, and 7000 mg — of the SARS-CoV-2 neutralizing antibody candidate for treating symptomatic COVID-19 in the outpatient setting. Data showed that primary endpoint of the study was met by the 2800 mg dosage of the candidate but not by the two other dosing regimens. Treatment with 2800mg dose achieved near complete viral clearance by day 11. Additional data showed that this dosing regimen achieved improvement in viral clearance as early as day 3 from the baseline.
Moreover, it was also observed that 1.7% of patients receiving any of the three doses of LY-CoV555 required hospitalization or ER visit compared to 6% for placebo, representing 72% reduction in risk. The antibody candidate was well tolerated.
Lilly stated that the data reaffirms its conviction that neutralizing antibodies can help in the fight against COVID-19.
Currently, Lilly is also evaluating LY-CoV555 in combination with another antibody candidate, LY-CoV016, in the ongoing BLAZE-1 study. Lilly is also conducting a phase III study that is evaluating LY-CoV555 for the prevention of COVID-19 in residents and staff at long-term care facilities.
Please note that the National Institutes of Health is also evaluating LY-CoV555 in two clinical studies — ACTIV-2 and ACTIV-3 — in ambulatory and hospitalized COVID-19 patients.
Lilly is making rigorous efforts to make medicines/antibodies to treat COVID-19. Lilly and its partner Incyte Corporation INCY are developing its rheumatoid arthritis drug, Olumiant (baricitinib) in combination with Gilead’s GILD remdesivir for hospitalized patients with COVID-19 infections. Earlier this week, Lilly announced that the phase III study evaluating the combination of Olumiant and remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir alone.
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. 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 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-COV2, a novel investigational antibody "cocktail" treatment, is currently being studied in two phase II/III clinical studies for the treatment of COVID-19.
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