GSK to deliver Australia’s first monoclonal antibody treatment for COVID-19

Pharma News: The Therapeutic Goods Administration (TGA) has granted a provisional determination to GlaxoSmithKline (GSK) Australia in relation to the monoclonal antibody treatment, VIR-7831 (referred by the TGA as SOTROVIMAB – GSK4182136).

Dr Krystal Evans, Medical lead for COVID therapeutics at GSK Australia, told Health Industry Hub “It’s really encouraging to see that the TGA have granted this provisional determination pathway for the first COVID-19 monoclonal antibody treatment, VIR-7831. It’s actually a medicine that’s being developed in collaboration between GSK and Vir Biotechnology.

“The lead indication for VIR-7831 is for the early treatment of COVID-19 to prevent the progression to hospitalisation and severe disease. We’re going to be able to add more tools in our toolkit as we look to manage our way through and out of the pandemic,” she added.

The granting of a provisional determination means that GSK is now eligible to apply for provisional registration for the treatment in the Australian Register of Therapeutic Goods (ARTG). GSK Australia will be working to support the TGA’s assessment and to provide them with the required data over the next few months.

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This new medicine would complement the rollout of the Pfizer and AstraZeneca vaccines to make major reductions to the impact of COVID-19.

“There may be a time when our public health system moves from being able to contact trace, test and isolate people to be able to contact trace, test and treat people to help them recover faster and reduce the community spread,” noted Dr Evans.

Another reason this treatment success is so exciting is that it may herald a breakthrough for this class of medicines – monoclonal antibody treatment of viral infection. Monoclonal antibody drugs have been most widely used to treat cancer and autoimmunity, but have had enormous potential to directly combat an infection. Further investment spurred by this outcome may help researchers understand how to best use this additional tool for global health.

Last month, Vir Biotechnology and GSK announced that the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation was stopped for enrolment due to evidence of profound efficacy.

The Independent Data Monitoring Committee (IDMC) recommendation was based on an interim analysis of data from 583 patients enrolled in the COMET-ICE trial, which demonstrated an 85% (p=0.002) reduction in hospitalisation or death in patients receiving VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial.

The company’s research on the COVID treatment has taken place internationally due to Australia’s low case numbers making it difficult to recruit for clinical trials.

As the Phase 3 COMET-ICE trial remains ongoing and blinded with patients continuing to be followed for 24 weeks, additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.