- Investigational antibody cocktail of casirivimab and imdevimab also significantly shortened the duration of symptoms by four days
- The 2,400 mg and 1,200 mg doses tested in the phase III study had similar efficacy across all endpoints
- Companion dose-ranging phase II trial showed significant and comparable viral reductions for a range of doses of casirivimab and imdevimab
- The combination of casirivimab and imdevimab is the only monoclonal antibody treatment to retain potency against key emerging variants, based on the recently updated EUA guidance from the U.S. FDA
Roche today confirmed positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalised patients (n=4,567; REGN-COV 2067). The phase III outcomes trial in high-risk non hospitalised patients with COVID-19 met its primary endpoint, showing the investigational antibody cocktail of casirivimab and imdevimab reduced the risk of hospitalisation or death by 70% (1,200 mg intravenously [IV]) and 71% (2,400 mg IV) compared to placebo.
Casirivimab and imdevimab also met all key secondary endpoints in the phase III REGN-COV 2067 trial, including the ability to reduce symptom duration from 14 to 10 days (median numbers). In addition, a companion phase II trial (REGN-COV 20145) in low risk symptomatic or asymptomatic non-hospitalised patients with COVID-19 showed significant and comparable viral load reductions across doses ranging from 300 to 2,400 mg.