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Junshi and Lilly to File for Emergency Use of Paired Antibodies for COVID-19

publication date: Oct 8, 2020
author/source: Richard Daverman, PhD

Junshi Bio (HK: 1877; SHA: 688180) of Shanghai and Lilly (NYSE: LLY) released positive interim data on their paired antibody treatment for COVID-19. In early results from a Phase II trial, the combination reduced viral load, symptoms and COVID-related hospitalization and ER visits. Detailed data will be released later in a journal article. Lilly plans to file for Emergency Use Authorization of the combination therapy for patients with mild-to-moderate COVID-19 in November 2020, followed by a BLA filing as early as Q2 2021.

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.

See our other articles on Junshi and Lilly.

Disclosure: none.




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