BioPharma

Vir Biotechnology, GSK Covid-19 antibody shows ‘profound efficacy’ in Phase 3 study

The positive data for the antibody drug from Vir Biotechnology and GlaxoSmithKline give a clearer picture of how and when these treatments could help. Last week, a different pivotal study testing the same drug in hospitalized patients yielded murkier results.

 

A Covid-19 drug candidate from Vir Biotechnology and GlaxoSmithKline has posted clinical trial results showing the treatment reduced the rate of hospitalization or death by 85% and the companies now plan to seek emergency authorization to bring the antibody to patients.

The Phase 3 study testing the drug, VIR-7831, enrolled about 1,300 patients in North America, South America, and Europe. Those patients had Covid infection, but their disease had not yet progressed to the point of requiring hospitalization. The main goal of the study was to show a reduction in hospitalization or death in patients who received the intravenously infused drug by itself compared to those given a placebo.

The drug from San Francisco-based Vir worked so well that the independent committee monitoring data from the study recommended stopping the clinical trial early due to “evidence of profound efficacy.” That finding was based on an interim analysis of 583 patients.

The Vir drug is a neutralizing antibody engineered to work in two ways: it blocks the virus’s entry into cells and clears away infected ones. The drug was also designed to reach high concentration in the lungs, enabling it to reach airway tissues affected by the novel coronavirus. The company engineered the virus to last longer and to enhance the function of virus-specific T cells, which the company has said could help treat or prevent Covid infection.

The Phase 3 clinical trial tested the Vir drug as an early treatment for Covid—patients not yet hospitalized but at high risk of needing to be admitted. The stage of the disease is important to note here. The finding in Thursday’s announcement comes a week after independent data analysis in a different Phase 3 clinical trial raised questions about the same Vir antibody in hospitalized patients. According to Vir and GSK, the data safety monitoring board for that study found “concerns about the magnitude of potential benefit” and recommended that enrollment be closed while the data mature.

The different clinical trial outcomes for VIR-7831 highlight an important aspect of drug development during a pandemic: Companies don’t know at which stage of a disease their drugs will be most effective, so they test them in multiple large studies, all conducted in parallel. The picture of which patients and what stage of disease is best to use a drug does not become clear until the results come out.

More studies are underway. The Vir antibody is part of a Phase 2 study sponsored by Eli Lilly. That trial is evaluating Lilly’s Covid-19 antibody drug bamlanivimab by itself and in combination with other neutralizing antibodies, including Vir’s. The placebo-controlled study is enrolling low-risk adults who have mild-to-moderate disease.

Vir and GSK have additional tests in the works for VIR-7831. The antibody is currently in a mid-stage study comparing an intramuscular injection to intravenous infusion in low-risk adults with mild-to-moderate disease. A Phase 3 trial is planned for the second quarter of this year assessing whether the intramuscular injection can reduce hospitalization or death from Covid infection in high-risk adults. And yet another late-stage study is planned in coming months testing the antibody in uninfected, but high-risk adults. The goal of this study is to assess whether the Vir antibody prevents symptomatic infection.

Vir and GSK began working together last April, aiming to use the biotech’s technology to develop drugs and vaccines addressing the novel coronavirus. The Vir platform identifies rare antibodies in people who have protection from an infectious disease or who have recovered from one. Those antibodies become the basis for the company’s drugs. The Vir technology has produced antibodies with potential applications addressing hepatitis B virus, influenza A, Ebola, and malaria.

The Vir and GSK alliance focused on two SARS-CoV-2 antibodies: VIR-7831 and VIR-7832. Last month, the partners agreed to expand the alliance to cover the development of antibody treatments for influenza and other respiratory viral diseases.

In the clinical trial results announced Thursday, Vir and GSK said VIR-7831 was well tolerated by patients, safety data that is consistent with earlier tests of the drug. With the safety and efficacy data in hand, the partners said they plan to seek emergency use authorization for the antibody in the U.S. and other countries. They added that the data from the latest study will also form the basis of a submission seeking formal FDA approval.

VIR-7831 is also showing the potential to address multiple variants of the novel coronavirus. Vir and GSK said they have new lab data showing that VIR-7831 maintains its activity against variants that have emerged from the U.K., South Africa, and Brazil. This Vir antibody was designed to bind to a part of the spike protein that is consistent across variants. This approach may make it more difficult for the virus to develop resistance to it. Results of a new study testing the antibody against those variants has been submitted for online publication. Vir and GSK said the data will be published as a pre-print, meaning they have not yet been peer-reviewed.

In other Covid-19 drug and vaccine news…

  • Roche announced that a pivotal study testing its rheumatoid arthritis drug tocilizumab (marketed as Actemra) failed the main goal of reducing the discharge time for patients with pneumonia caused by Covid infection. The drug was tested in combination with Gilead Sciences antiviral remdesivir (Veklury) compared to treatment with the Gilead drug alone.
  • Partners Pfizer and BioNTech, along with the Israel Ministry of Health, reported real-world data showing “dramatically lower” rates of Covid disease in those who were fully vaccinated with the companies’ messenger RNA vaccine. The companies said the data confirm and build upon previously released data from Israeli officials showing that the vaccine was effective in preventing infection, hospitalization, and death from the novel coronavirus.
  • Johnson & Johnson’s one-shot Covid vaccine received a positive opinion from a European Medicines Agency committee, moving the company one step closer to bringing the product to Europeans. The vaccine received emergency authorization from the FDA on Feb. 27.

Image: appledesign, Getty Images

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