GSK COVID-19 Antibody Elicits 85% Drop in Hospitalizations, Deaths

Vir Biotechnology and GlaxoSmithKline (GSK) are stopping a Phase 3 clinical trial of its COVID-19 antibody early after data shows “profound efficacy,” according to a recent announcement from the companies.

The COMET-ICE trial assessed the safety and efficacy of a single 500 milligram intravenous infusion of the antibody, VIR-7831, or a placebo in 583 non-hospitalized participants globally.

The primary efficacy endpoint was the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization. 

Overall, researchers found an 85 percent reduction in hospitalization or death in patients who received the antibody as monotherapy compared to placebo.

Therefore, the Independent Data Monitoring Committee (IDMC) recommended that the trial stop enrollment.

However, current trial patients will continue to be followed for 24 weeks so researchers can gather additional results, including epidemiology and virology data. Due to the positive trial results, the companies plan to submit emergency use authorization to FDA.

“We are pleased that this unique monoclonal antibody was able to bring such a profound benefit to patients. We look forward to the possibility of making VIR-7831 available to patients as soon as possible and to further exploring its potential in other settings,” Hal Barron, MD, chief scientific officer and president of research and development at GSK, said in the announcement. 

In addition to the COMET-ICE trial results, GSK and Vir Biotechnology announced the results of a new study submitted and pending online application in bioRxiv, which showed that VIR-7831 maintains activity against current circulating variants of concern.

These variants of concern include the UK, South African, and Brazilian strains.

Compared to other monoclonal antibodies, VIR-7831 binds to a conserved epitope of the spike protein, GSK explained. This makes it more difficult for resistance to develop. 

The full COMET clinical development program for VIR-7831 includes COMET-PEAK, COMET-TAIL, and COMET-STAR.

COMET-PEAK is an ongoing Phase 2 trial to compare the safety and viral kinetics of 500 milligrams of VIR-7831 to 500 milligrams VIR-7831 among low-risk adults with mild to moderate COVID-19.

The second part of the trial will evaluate the similarity and pharmacokinetics between VIR-7831 manufactured by different processes.

COMET-TAIL is a Phase 3 trial that will assess VIR-7831 in high-risk adults. And COMET-STAR is a Phase 3 trial that will assess whether the antibody can prevent symptomatic infection in uninfected adults.

Both trials are expected to begin in the second quarter of this year. 

Additionally, VIR-7831 is being evaluated in the outpatient setting in a Phase 2 trial sponsored by Eli Lilly & Company. 

The trial will assess Eli Lilly & Company’s COVID-19 antibody, bamlanivimab, alone versus bamlanivimab with VIR-7831 in low-risk adults with mild to moderate COVID-19. 

“The dual-action design of VIR-7831 to both block viral entry into healthy cells and clear infected cells, as well as its high barrier to resistance, are key distinguishing characteristics,” said George Scangos, PhD, chief executive officer of Vir Biotechnology.

“These findings, paired with our pending publication of resistance data, demonstrate the potential of VIR-7831 to prevent the most severe consequences of COVID-19 and highlight its potential ability to protect against the current circulating strains of the virus.”

In January, GSK and Vir Biotechnology announced an agreement with UK-based AGILE initiative to evaluate the company’s second COVID-19 antibody, VIR-7832, in a Phase 1b/2a clinical trial. 

The AGILE trial platform will use adaptable protocols and statistical models to evaluate VIR-7832 in patients with mild-to-moderate COVID-19. 

In previous clinical trials, data has suggested that VIR-7832 has two distinguishing properties, including an enhanced ability to clear infected cells and the potential to enhance virus-specific T-cell function. 

Therefore, the companies are confident that the antibody will elicit positive results against COVID-19 in future trials. The AGILE trial is expected to begin in the first quarter of this year.