Lilly-Vir mAb cocktail could expand treatment to low-risk COVID-19 patients
Top-line Phase II data for a combination of mAbs from Vir and Lilly could open the door to a mAb treatment for a new COVD-19 population: low-risk outpatients.
Three mAb therapies have emergency use authorization to treat COVID-19 in high-risk outpatients: bamlanivimab from Eli Lilly and Co. (NYSE:LLY) and AbCellera Biologics Inc. (NASDAQ:ABCL); the combination of bamlanivimab plus etesevimab, which Lilly developed with Shanghai Junshi Biosciences Co. Ltd. (HKEX:1877; Shanghai:688180); and the two-mAb cocktail REGEN-COV-2 from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN).
None of those EUAs cover low-risk patients.
Lilly, Vir Biotechnology Inc. (NASDAQ:VIR), and Vir partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said Monday that bamlanivimab plus VIR-7831, administered to low-risk COVID-19 outpatients, met the primary endpoint in the BLAZE-4 trial. Co-administration of 700 mg bamlanivimab and 500 mg VIR-7831, which Vir discovered, led to a 70% reduction vs. placebo (p<0.001) in the percentage of patients with persistently high SARS-CoV-2 load.
Persistently high viral load is a predictor of worse COVID-19 outcomes and was defined in the trial as SARS-CoV-2 titers with log10 values >5.27, measured using a qPCR assay through day seven.
Bamlanivimab plus VIR-7831 also met secondary endpoints of lowering viral loads at days three, five and seven.
No conclusions can be drawn from the study about the combination’s effect on symptoms. No patients in either arm of the study were hospitalized or died; one patient in the treatment cohort visited the ER for COVID-19-related symptoms.
The companies plan to discuss EUA submissions for the combination with FDA and regulators in other countries.
Lilly partnered with Vir and GSK in January to address emerging viral variants. At the time, preclinical data had begun emerging on mAb vulnerabilities to SARS-CoV-2 escape mutations.
Last week, Lilly and the U.S. government stopped distributing bamlanivimab for monotherapy use due to lost potency against variants circulating in the U.S.; the mAb remains available for use with etesevimab.
So far, preclinical data show VIR-7831 is largely resilient to emerging variants, and Vir believes it could serve both as a standalone therapy and as a backbone for combinations. Vir has applied for an EUA for VIR-7831 as monotherapy based on data from the Phase II/III COMET-ICE study.