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Junshi and Lilly to File for Emergency Use of Paired Antibodies for COVID-19
Junshi Bio (HK: 1877; SHA: 688180) of
The randomized, double-blind, placebo-controlled Phase II trial evaluated Junshi's JS016 and Lilly's LY-CoV555 (from Lilly’s collaboration with AbCellera) in newly diagnosed outpatients with mild to moderate disease. The two antibody molecules bind complementary regions of the SARS-CoV-2 spike protein.
At day 11, the combination therapy significantly reduced viral load (p=0.011), meeting the primary endpoint of the study. Most patients, including those receiving placebo, demonstrated near complete viral clearance by day 11.
The combination treatment reduced viral levels at day 3 (p=0.016) and day 7 (p<0.001)—earlier time points during the course of infection when higher viral loads are typically seen. Combination therapy also significantly reduced time-weighted average change from baseline from day 1 to 11. An analysis showed that the proportion of patients with persistently high viral load at day 7 for combination therapy was lower (3.0 percent) versus placebo (20.8 percent), corresponding to a nominal p value of p<0.0001 without multiplicity adjustment. No emergent resistance variants were observed.
The combination therapy was generally well tolerated with no drug-related serious adverse events.
Based on the combination therapy data, Lilly has engaged global regulators, including the FDA regarding a potential EUA. Lilly expects to submit a request for EUA for combination therapy in November, pending clinical trial enrollment, once additional safety data accumulate and sufficient supply is manufactured. Lilly anticipates having data to support a biologics license application (BLA) submission for combination therapy as early as Q2 2021. Conversations with global regulators are ongoing.
The BLAZE-1 clinical trial is continuing to enroll a confirmatory cohort of higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19, testing the ability of the antibody combination to reduce the number of patients with persistently high viral load and reduce COVID-related hospitalizations. In addition, Lilly is studying lower doses of combination therapy and alternative delivery options in planned or ongoing clinical trials.