EMA Reviews GSK/Vir’s Dual-Action Monoclonal Antibody VIR-7831 for Early Treatment of High-Risk COVID-19 Patients Amid Global Cases Surpassing 139 Million

April 16, 2021 News /Bio ValleyBIOON/ -- At present, the COVID-19 epidemic overseas is still spreading rapidly. According to Baidu's "Real-time Data on the Novel Coronavirus Pneumonia Epidemic"Big DataReport》, as of 00:00 on April 16, 2021, the global cumulative confirmed cases exceeded 130 million (139.1 million), with more than 2.98 million deaths.

Recently,GlaxoSmithKline(GSK) and Vir Biotechnology jointly announced that the European Medicines Agency (EMA) has begun its review of VIR-7831 (GSK4182136), a dual-acting monoclonal antibody against SARS-CoV-2, for the treatment of adults and adolescents (aged 12 years and older, weighing at least 40 kg) who do not require supplemental oxygen and are at high risk of progressing to severe COVID-19.

Pursuant to Article 5(3) of Regulation (EC) No 726/2004, the Committee for Medicinal Products for Human Use (CHMP), a body under the European Medicines Agency (EMA), is conducting a review and will provide EU-wide scientific advice to regulatory authorities in EU Member States, enabling these national regulators to make evidence-based decisions regarding the early use of medicines prior to any formal marketing authorization application.

This review will include interim analysis data on the efficacy and safety from the Phase 3 COMET-ICE (COVID-19 Monoclonal Antibody Efficacy Trial – Intent to Care Early) trial. The trial evaluated the efficacy of VIR-7831 as monotherapy for early treatment in adult patients with COVID-19 at high risk of hospitalization. Interim analysis based on data from 583 randomized patients showed that the trial met its primary endpoint: an 85% reduction in hospitalization or mortality rates among patients treated with VIR-7831 compared to placebo (p=0.002). Consequently, the Independent Data Monitoring Committee (IDMC) recommended halting the trial due to evidence of significant efficacy. The CHMP review will also consider data regarding drug quality and safety.

This week, the Therapeutic Goods Administration (TGA), under the Australian Department of Health, granted a provisional determination for VIR-7831. VIR-7831 is the first anti-SARS-CoV-2 monoclonal antibody to receive this designation. The provisional determination provides a formal and transparent mechanism to accelerate the registration of promising new medicines using preliminary clinical data. While granting a provisional determination is a prerequisite for the provisional approval pathway, it does not guarantee that the submission for registration will be accepted or that provisional registration on the Australian Register of Therapeutic Goods (ARTG) will be successfully achieved.

In late March, GSK and Vir submitted to the U.S. Food and Drug Administration (FDA) submitted an application requesting Emergency Use Authorization (EUA) for VIR-7831 for the treatment of adults and adolescents (aged 12 years and older, weighing at least 40 kg) with mild to moderate COVID-19 who are at high risk of progression to hospitalization or death. This EUA submission is also based on the interim analysis data from the aforementioned Phase 3 COMET-ICE trial.

VIR-7831 is a dual-action monoclonal antibody against the novel coronavirus (SARS-CoV-2). Preclinical data indicate that VIR-7831 has the potential to both block viral entry into healthy cells and clear infected cells. VIR-7831 binds to an epitope shared by SARS-CoV-2 and SARS-CoV-1 (the virus causing SARS), suggesting that this epitope is highly conserved, which may make the development of resistance more difficult. Incorporating Xencor’s Xtend technology, VIR-7831 is also designed to achieve high concentrations in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2, while featuring an extended half-life.

Preclinical data also indicate that VIR-7831 targets a highly conserved epitope on the SARS-CoV-2 spike protein, which may make the development of resistance more difficult. New in vitro data from pseudotyped virus analyses, published online in March 2021 on the preprint server BioRxiv, support this hypothesis, confirming that VIR-7831 retains activity against current variants of concern, including the UK, South African, and Brazilian variants. According to other preclinical data published on BioRxiv, VIR-7831 also appears to maintain activity against the California variant. (Bioon.com)

Original Source: GSK and Vir Biotechnology Announce EMA Review of Dual-Action Monoclonal Antibody VIR-7831 for the Early Treatment of COVID-19