In a first major success for Vir and GSK after a setback just days ago, the duo announced on March 11th that an independent monitoring committee has found their COVID-19 antibody therapy, VIR-7831, effective in early-stage COVID-19 patients at reducing the risk of hospitalization and death by 85% and has recommended stopping enrollment of any new patients in the COMET-ICE trial. The company faced a setback on March 3rd when the National Institute of Health stopped studying the drug under the ACTIV-3 program in hospitalized patients for lack of benefit.
Antibody drugs for COVID-19 gained popularity when they were used to treat the former president of the US and several other high-profile politicians in November. The treatments are made up of lab-made antibodies that directly neutralize the virus. Currently, two of these antibody drugs from Regeneron, and Eli Lilly are authorized for emergency use. Based on the data from the COMET-ICE trial, Vir and GSK will also approach the USFDA for securing an emergency authorization for their treatment.
The therapy was also found effective against the newly evolved circulating variants of the virus that emerged from the UK, South Africa, and Brazil. Its effectiveness against the new variants comes from its ability to bind a highly conserved epitope of the spike protein, making it more difficult to change or mutate.
Vir’s medicine is similar to Regeneron’s and Lilly’s treatments in terms of the patient population it benefits the most. The drug is most effective when given early during infection. However, unlike these two, Vir’s treatment has just one antibody that does the work. Regeneron and Lilly are using a cocktail of treatments that consist of two antibodies that target the virus at two different locations.
George Scangos, Ph.D., Chief Executive Officer of Vir, said: “These exciting data with a single antibody against a conserved epitope bring us one step closer to delivering an effective new solution to patients around the globe. 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. 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.”
The recommendation by the monitoring committee was given after careful evaluation of the data derived from the COMET-ICE trial. In the trial, 583 patients were either given a single intravenous infusion of VIR-7831 antibody or placebo. The proportions of people who progressed to hospitalization for at least 24 hours or died within 29 days of randomization were calculated to determine the drug’s efficacy.
Interestingly, most patients in the study included Hispanic or Latinx, which according to the CDC, are approximately three times more likely to be hospitalized and approximately two times more likely to die. The patients enrolled in the study will be monitored for the next 24 weeks, and additional results, which include epidemiology and virology data, will be revealed later on.
What’s Next for Vir and GSK?
Vir and GSK are also testing their antibody drug in three other trials that would determine the efficacy of the drug administered via the muscular route. COMET-PEAK is comparing the safety and kinetics of intramuscularly administered drug to intravenous administration of the drug. COMET-TAIL and COMET-STAR will determine whether this route is effective at reducing hospitalization or death due to COVID-19 infection and also if it can prevent symptomatic infection. A Phase 3 trial of the intramuscular formulation in high-risk adults is due to start in the second quarter.
The market interest in Vir and GSK’s antibody med is, however, not clear considering the slow uptake of other approved antibody therapies for the COVID-19 infection. The demand for the antibody drug is much less than expected, and the doctors are confused as to which group of patients will benefit from this medication. Topping that, the approval of three vaccines has slowed down the uptake of these drugs. Despite that, Vir’s trial data marks a big moment for the company whose faith in its platform has now strengthened many folds. This will also boost its plans and confidence in venturing into other infectious diseases.
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