GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology Inc (NASDAQ:VIR) expect to request EUA (Emergency Use Authorization) for its innovative formulation – VIR7831. It is on the backdrop of an independent data monitoring committee (IDMC) recommending halting phase 3 COVID-19 Monoclonal antibody Efficacy (Phase 3 COMET-ICE) trials following the evidence of an 85% reduction in early deaths.
The recommendation of IDMC is based on analyzing data obtained from 583 patients in the COMET-ICE trial. An 85% success rate reduces the need for hospitalizations or deaths in patients treated with VIR7831 compared to placebo. The drug is well tolerated in the clinical trial.
The trial needs to be conducted for another 24 weeks to get additional details like virology and epidemiology data. But, IDMC data suggests the drug is safe and achieves a primary endpoint.
Expects EUA
GlaxoSmithKline and Vir will seek EUA (Emergency Use Authorization) for its innovative drug candidate – VIR7831 from the FDA in the US and other nations worldwide. They will also request for BLA (Biologics License Application) for this drug considering the data obtained from this ongoing clinical trial.
Announces the results of VIR-7831
Both the companies also released the results of this new study that indicates VIR-7831 actively works against the mutating coronavirus variants found in Brazil, South Africa, and the UK. It is based on an in-vitro analysis conducted on pseudotyped virus assays. According to the study’s findings, VIR-7831 binds to the spike protein and inhibits resistance to develop.
The VIR-7831’s full COMET clinical trial comprises COMET-TAIL, COMET-PEAK, and COMET-STAR.
In the ongoing COMET-PEAK trial, the viral kinetics and safety of 500 mg of VIR-7831 administered intramuscularly are compared with 500 mg of VIR-7831 administered in patients with moderate to low-risk coronavirus patients. The trial will identify the similarities between the pharmacokinetics of VIR-7831 manufactured through different processes.
The Phase 3 trial – COMET TAIL will commence in Q2 2021 in patients with high-risk coronavirus. In this trial, the drug’s efficacy is measured to detect whether it can lower the death caused due to coronavirus or reduce hospitalization.
Another Phase 3 clinical trial – COMET-STAR will begin in Q2 2021 in patients who are not infected but at high coronavirus, risk to determine whether the drug can eliminate the symptomatic infection.
