GlaxoSmithKline (GSK) and Vir Biotechnology’s investigational monoclonal antibody (mAb) sotrovimab has demonstrated continued promise in high-risk patients with mild-to-moderate COVID-19.
Final results from the phase 3 COMET-ICE trial demonstrated that sotrovimab significantly reduces the risk of hospitalisation or death among high-risk adult patients with COVID-19.
A primary efficacy analysis of 1,057 patients in the trial demonstrated a 79% reduction in hospitalisation for more than 24 hours or death due to any cause by day 29 compared to placebo.
Previously, interim trial results from the phase 3 trial evaluating the mAb found that sotrovimab reduced the risk of hospitalisation for more than 24 hours or death by 85% compared to placebo.
In the sotrovimab arm, just 1% of patients were hospitalised for over 24 hours for acute management of any illness or death from any cause at day 29, compared to 6% in the placebo arm.
In addition, researchers found that it is ‘possible’ that half of those patients who were hospitalised were for reasons other than progression of COVID-19 in the sotrovimab arm, which was not the case for the patients in the placebo arm.
On the safety front, the most common adverse events observed in the sotrovimab arm in the COMET-ICE trial were rash and diarrhoea, all of which were mild or moderate.
“Effective medicines to treat those who become infected with SARS-CoV-2 remain a critical part of the solution to this pandemic,” said Christopher Corsico, senior vice president of development, GSK.
“We are working diligently to increase access to sotrovimab in the US and across the globe, including evaluating the potential to simplify administration with an intramuscular formulation,” he added.
Meanwhile, the US National Institutes for Health (NIH) has updated its COVID-19 treatment guidelines to include sotrovimab as a treatment for non-hospitalised patients with mild-to-moderate COVID-19, who are at high risk of clinical progression.
According to GSK and Vir, the NIH has also noted that the mAb appears to retain activity against current variants of concern and interest.
The European Medicines Agency (EMA) has also issued advice for the use of sotrovimab for the treatment of COVID-19.
Following a review of the mAb, the EMA concluded that the sotrovimab can be used to treat high-risk COVID-19 patients.
The agency’s advice can be used to support national advice for European Union member states on the potential use of the mAb prior to a marketing authorisation for the treatment.