Eli Lilly, Vir Biotechnology and GlaxoSmithKline’s (GSK) neutralising antibodies have demonstrated positive results in a mid-stage study in low-risk COVID-19 patients.
The phase 2 BLAZE-4 trial, studying Lilly’s bamlanivimab co-administered with Vir/GSK’s VIR-7831, found that the combination therapy reduced viral load by 70% at day seven compared to placebo – the primary endpoint of the trial.
Bamlanivimab administered with VIR-7831 also demonstrated a statistically significant reduction in key virologic secondary endpoints compared to placebo.
The companies said there were no events for the secondary endpoint of COVID-19 related hospitalisation or death by day 29 in either study arm, with one patient in the treatment arm visiting an accident & emergency department for COVID-19-related symptoms.
The two neutralising antibodies bind to different epitopes of the SARS-CoV-2 spike protein – bamlanivimab is directed against the SARS-CoV-2 spike protein and is designed to block viral attachment and entry into human cells, while VIR-7831 has the potential to both block viral entry into health cells and clear infected cells.
VIR-7831 has previously demonstrated the ability to neutralise the SARS-CoV-2 virus, which causes COVID-19, both in vitro and in vivo.
In addition, GSK and Vir announced earlier this month that VIR-7831 demonstrated an 85% reduction in the hospitalisation or death in high-risk COVID-19 patients treated early with VIR-7831 monotherapy compared to placebo, in the COMET-ICE trial.
Lilly’s bamlanivimab has already been found to reduce the risk of COVID-19 infections in residents and staff in care homes, and also to reduce the risk of hospitalisations and deaths in high-risk COVID-19 patients when combined with its other antibody etesevimab.
“The reduction in persistently high viral load is an important virology endpoint that was demonstrated in Lilly’s Phase 2 BLAZE-1 trial, and subsequently validated in the phase 3 trial, to be strongly correlated with the clinical outcome of COVID-19-related hospitalisations and deaths in high-risk patients,” said Daniel Skovronsky, chief scientific officer of Lilly and president of Lilly Research Laboratories
“This virology data supports our belief that bamlanivimab and VIR-7831 together could be a promising option for COVID-19 treatment,” he added.
GSK and Vir have submitted an emergency use authorisation (EUA) application to the US Food and Drug Administration (FDA) for VIR-7831 based on the results from the COMET-ICE trial.
Bamlanivimab is authorised under an EUA for the treatment of high-risk mild-to-moderate COVID-19 in adults – and paediatric patients who are at least 12 years of age and weigh at least 40kg – who have tested positive for the virus.
Lilly, GSK and Vir said they ‘anticipate’ engaging with regulatory authorities across the globe – including the FDA – regarding the potential co-administration of bamlanivimab and VIR-7831 for the treatment of COVID-19.