COVID-19: Eli Lilly Claims Efficacy, Seeks Speedy Emergency Use Authorization for Antibody Therapy
By T. Chakraborty, Ph.D.
As the clock keeps ticking, scientists worldwide are trying their best to develop an effective cure for COVID-19. Among the frontrunners, Moderna and AstraZeneca’s vaccine candidates deserve special mention as they are in their final Phase of clinical trials. On October 7th, Eli Lilly announced further details of their in-house SARS-CoV-2 neutralizing antibody programs. The press release reported data on combination therapy in patients diagnosed with mild-to-moderate COVID recently .
Daniel Skovronsky, M.D., Ph.D., Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories, added, “Our teams have worked tirelessly the last seven months to discover and develop these potential antibody treatments. We believe the data generated to date provide sufficient evidence that both monotherapy and combination therapy may be effective to treat COVID-19 in patients with a high risk for serious outcomes. Lilly is diligently working with regulators around the world to make these treatments available.” 
LY-CoV555 and LY-CoV016
LY-CoV555 is a monoclonal antibody that binds to the spike protein of SARS-CoV-2. This antibody blocks the attachment of the virus to the host cells. LY-CoV555 was developed by a collaboration between Lilly and AbCellera. The antibody was identified from a patient who recovered from COVID-19. Currently, multiple monotherapy and long-term studies are ongoing with this antibody.
LY-CoV016 is another recombinant monoclonal antibody that binds to the viral surface spike protein receptor-binding domain. Pre-clinical studies in monkeys have shown that this antibody can cure SARS-CoV-2 infection. Lilly licensed it from Junshi Biosciences after it was jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science (IMCAS). A Phase I trial is ongoing to test the efficacy and safety of the drug .
BLAZE-1 is a Phase II, randomized double-blinded clinical trial that evaluated the efficacy and safety of the combination treatment of two antibodies, LY-CoV555 and LY-CoV016, which binds complementary to the spike protein of the virus. A total of 268 patients with mild to moderate COVID-19 were enrolled in the study. Out of the 268 patients, 112 patients received the antibody combinations, while the remaining patients were in the placebo group.
All groups, including placebo, had reduced viral load by 11 days. Combination therapy reduced the viral load by 3 days and 7 days when the viral load was higher in general. No viral resistance was observed. Combination therapy further improved the time-weighted average change from baseline in total symptom score from day 1 to 11. Hospitalization from COVID was also reduced post combination therapy compared to the placebo group. This data from combination therapy was similar to the monotherapy with LY-CoV555. The combination therapy was well tolerated in the patients .
This kind of combination therapy is similar to the cocktail therapy developed by Regeneron, REGN-COV2. Regeneron released the data from their trial last week. With Eli Lilly rushing to get their combination therapy and monotherapies approved by FDA, the race for capturing the market for treatment against COVID-19 is getting tighter. At the moment, both Regeneron and Eli Lilly’s antibody therapies have backing from the US President, Donald Trump, who is recovering from the disease. However, it remains to be seen how these candidates would overcome the FDA’s newly updated guidelines for EUA.
Editor: Rajaneesh K. Gopinath, Ph.D.
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