Roche’s drug cocktail reduces hospitalisation due to COVID-19 in Phase III trial
pharmafile | March 24, 2021 | News story | Research and Development | COVID-19, Roche, covid-19 treatment
Roche’s antibody drug combination of casirivimab and imdevimab has shown to reduce hospitalisation or death by 70% in non-hospitalised patients with COVID-19 in a Phase III trial.
The randomised, double-blind study compared the efficacy, safety and tolerability of casirivimab and imdevimab versus a placebo in 4,567 patients with COVID-19.
The primary endpoint of significantly reducing hospitalisation was reached in both participants who received 2,400mg, and 1,200mg doses of the treatment.
The combination of casirivimab and imdevimab is currently the only monoclonal antibody treatment to retain potency against key emerging variants of the COVID-19 virus.
The two drugs also met all secondary endpoints in the trial, including the ability to reduce symptom duration from 14 to 10 days on average. A companion Phase II trial in low risk symptomatic or asymptomatic non-hospitalised patients with COVID-19 also showed significant viral load reductions in patients, with doses ranging from 300 to 2,400mg.
In addition to these trials in non-hospitalised patients, casirivimab and imdevimab are currently being studied in Phase II and III trials for the treatment of COVID-19 in hospitalised patients.
There have been 124 million confirmed cases of COVID-19 worldwide, with 2.73 million reported deaths.
Dr Levi Garraway PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said: “Today’s results show the important medical benefit casirivimab and imdevimab may provide to people with COVID-19 by significantly reducing their risk of hospitalisation and death.
“New infections continue to rise globally with over three million reported cases last week, so this investigational antibody cocktail may offer hope as a potential new therapy to high-risk patients – particularly in light of recent evidence showing that casirivimab and imdevimab together retain activity against key emerging variants.”
He continued: “Together with our partner Regeneron, we are grateful to the patients and investigators who have participated in ongoing clinical trials and look forward to discussing the growing body of evidence with health authorities and to bringing the treatment to as many people as possible.”
Jack Goddard
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