Eli Lilly coronavirus drug, Indy-based Eli Lilly moves into late-phase testing of COVID-19.

The Indianapolis-based pharmaceutical firm Eli Lilly and Company on Monday said it had advanced testing of a promising COVID-19 treatment into “Phase 3,” signalling optimism that the treatment could prove to be effective and safe.

The new stage of trials will test LY-CoV555, a treatment developed in partnership with Canadian biotech AbCellera.

Lilly and AbCellera will enroll up to 2,400 participants who live or work at a long-term residential facility or nursing home that has had a recently diagnosed case of COVID-19.

“COVID-19 has had a devastating impact on nursing home residents,” said Dr. Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories. “We’re working as fast as we can to create medicines that might stop the spread of the virus to these vulnerable individuals.”

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The advancement of testing comes two months after Lilly said it had begun the world’s first study of a potential COVID-19 antibody treatment.

About LY-CoV555 (via Eli Lilly):
LY-CoV555 is a potent, neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19. LY-CoV555 emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and tested by the scientists at the NIAID Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

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Lilly has successfully completed dosing of LY-CoV555 in a Phase 1 study of hospitalized patients with COVID-19 (NCT04411628) and long-term follow-up is ongoing. BLAZE-1, a Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting (NCT04427501), is ongoing. Based on current trends, enrollment is estimated to be completed in September, with initial data readout soon thereafter followed by full data in Q4. LY-CoV555 has been well tolerated at all doses tested and no drug-related severe adverse events (SAEs) have been observed to date. Efficacy data are not yet available.

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Lilly is committed to the rapid release of important scientific data. Large-scale manufacturing of this potential therapy continues, with the goal of having more than one hundred thousand doses available by the end of the year should LY-CoV555 prove to be a meaningful therapeutic option for COVID-19.

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