Eli Lilly And Co LLY shares are advancing Wednesday after the company issued an update on its anti-COVID-19 antibody program.
What Happened: Lilly announced data from a new interim analysis of its antibody cocktail and submission of an initial request for EUA for antibody monotherapy. The company also provided an update on manufacturing and supply arrangements.
Combo Antibody Therapy Effective, Safe: The Phase 2 BLAZE-1 clinical trial that evaluated Lilly's antibodies LY-CoV555 and LY-CoV016 for the treatment of symptomatic COVID-19 in the outpatient setting showed the combo therapy significantly reduced viral load at day 11, meeting the primary endpoint of the study.
The combination treatment reduced viral levels at day 3 and day 7 —earlier time points during the course of infection when higher viral loads are typically seen, the company said.
Lilly also noted that the rate of COVID-related hospitalization and ER visits was lower for patients treated with combination therapy versus placebo.
The combo was also generally well tolerated with no drug-related serious adverse events.
On most counts, the combo treatment produced a similar effect as that of the LY-CoV555 monotherapy, Lilly said.
EUA Request Filed For Monotherapy: Lilly said it has submitted to the FDA an initial request for EUA for LY-CoV555 monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19, based on the combo therapy data and the previously disclosed findings for the monotherapy.
The company also said it has engaged with other global regulators as well.
Lilly expects to submit a EUA request for the combo therapy in November, contingent on clinical trial enrollment, accumulation of additional safety data and availability of sufficient supply.
A BLA submission for the combo therapy could be made as early as the second quarter of 2021, the company said.
Lilly also plans an open-label study in the coming weeks, enrolling patients treated with either monotherapy or combination therapy, to generate additional efficacy and safety data.
Lilly's Manufacturing Plans: To ensure global supply, Lilly said it has invested in large-scale manufacturing of both antibodies at risk. The company expects to supply as many as one million doses of 700 mg LY-CoV555 monotherapy in the fourth quarter, with 100,000 available in October.
The company said it will make available 50,000 doses of the combo therapy in the fourth quarter, with supply increasing substantially beginning in the first quarter.
At last check, Lilly shares were rallying 3.3% to $148.88.
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