Top-line results from the Phase II BLAZE-4 study showed that combining Eli Lilly's bamlanivimab with GlaxoSmithKline and Vir Biotechnology's VIR-7831 led to a 70% relative reduction in persistently high viral load at day seven compared to placebo in low-risk adults with mild-to-moderate COVID-19, the companies announced Monday. Daniel Skovronsky, president of Lilly Research Laboratories, called reduction in persistently high viral load "an important virology endpoint," and the companies said they plan to engage with global regulators, including the FDA, about the possibility of co-administrating bamlanivimab with VIR-7831 to treat COVID-19.
The BLAZE-4 trial, which has a target enrolment of 1000 participants in the US and Puerto Rico, is assessing the efficacy of bamlanivimab, together with other neutralising antibodies such as VIR-7831, against placebo to treat symptomatic low-risk COVID-19 in the outpatient setting. The primary outcome measure is the percentage of participants who have a viral load >5.27 at day seven.
In addition to meeting the main goal, the combination of bamlanivimab and VIR-7831 also demonstrated a significant reduction compared to placebo in the key virologic secondary endpoints of mean change from baseline to days three, five and seven in SARS-CoV-2 viral load. The companies noted that while there were no events for the secondary endpoint of COVID-19-related hospitalisation or death by day 29 in either arm of the study, one patient in the combination arm visited the emergency room for COVID-19-related symptoms. Meanwhile, there were no significant adverse events reported involving co-administration of bamlanivimab plus VIR-7831.
George Scangos, CEO of Vir, remarked "this virologic evaluation of two antibodies with distinct resistance profiles is an encouraging advance in our fight against the pandemic," while recent preclinical data for VIR-7831 suggest it "maintains activity against current circulating variants of concern."
Last week, the US government stopped distribution of bamlanivimab monotherapy – roughly four months after it was greenlighted by the FDA – due to concerns about emerging SARS-CoV-2 variants in the country. However, delivery sites can still order bamlanivimab to be administered with Eli Lilly's etesevimab, a combination that has also been authorised by the agency for emergency use. Bamlanivimab and VIR-7831 bind to different regions of the SARS-CoV-2 spike protein, and the two together "may provide protection against current variants…that are resistant to bamlanivimab," the companies said.
A request to grant VIR-7831 monotherapy an emergency-use authorisation was submitted to the FDA last week based on interim data from the Phase III COMET-ICE trial showing an 85% reduction in hospitalisation or death among patients receiving the dual-action monoclonal antibody compared to placebo. Hal Barron, president R&D at GlaxoSmithKline, said the BLAZE-4 and COMET-ICE results "support our hypothesis that by targeting a highly conserved epitope of the SARS-CoV-2 spike protein, VIR-7831 may help deliver benefits to patients."
To read more Top Story articles, click here.