GlaxoSmithKline (GSK) and Vir Biotechnology have reported positive final, confirmatory data from the Phase III COMET-ICE clinical trial of sotrovimab in high-risk adults with mild-to-moderate Covid-19 in the outpatient setting.
Data showed that the experimental SARS-CoV-2 monoclonal antibody significantly lowered the risk of hospitalisation or death.
According to primary efficacy analysis of all 1,057 participants, the COMET-ICE trial’s primary endpoint was met with a 79% decrease in hospitalisation for more than 24 hours or death from any cause by day 29 versus placebo.
Six subjects treated with sotrovimab were hospitalised for more than 24 hours for acute management of any illness or death due to any cause at day 29, compared to 30 patients on placebo.
In 50% of hospitalised patients who received the drug candidate, the reasons for hospitalisation could be other than disease progression, the companies noted.
Safety analysis of the trial involved follow-up of 1,037 patients through a minimum of 29 days.
The most common sotrovimab-related adverse events were mild or moderate rash and diarrhoea. Results did not show any additional treatment-emergent adverse events at a higher rate when compared to placebo.
Based on data from the COMET-ICE trial, the US National Institutes of Health (NIH) recommended sotrovimab to treat non-hospitalised mild-to-moderate Covid-19 patients who are at high clinical progression risk, in a recent update of its COVID-19 treatment guidelines.
The NIH added that the drug appears to maintain activity against existing variants of concern and interest.
COMET-ICE was halted early in March last year after interim data revealed an 85% decrease in hospitalisation for more than 24 hours or death when treated with sotrovimab.
Vir Biotechnology CEO George Scangos said: “These results, combined with the growing number of pending global authorisations, as well as the recent recommendation by the NIH COVID-19 Treatment Guidelines Panel, support our confidence in the potential role of sotrovimab in the fight against this pandemic.”
Sotrovimab is being further assessed in the COMET clinical development programme, including the COMET-PEAK trial to test an intramuscular formulation of the drug.