Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%

• Among individuals who still experienced symptomatic infections, those who received casirivimab and imdevimab were able to clear the virus faster and had much shorter symptom duration
• In a cohort of recently-infected asymptomatic patients, casirivimab and imdevimab reduced the overall risk of progressing to symptomatic COVID-19 by 31%
• Detailed results will be shared with regulatory authorities including the EMA and the FDA

Basel, 12 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive results from the phase III REGN-COV 2069 trial assessing the ability of the investigational antibody cocktail casirivimab and imdevimab to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals. The trial, which was jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), met its primary and key secondary endpoints. It showed that the subcutaneous administration of casirivimab and imdevimab reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial. In addition, individuals treated with casirivimab and imdevimab who still experienced a symptomatic infection resolved their symptoms on average within one week, compared to three weeks with placebo. No new or serious safety signals were observed.

“Today’s data confirm the potential dual value of casirivimab and imdevimab to reduce household COVID-19 infections and to decrease the disease burden in those who do become infected, when given as a subcutaneous option,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Although vaccinations are increasing globally, there remains a critical unmet need worldwide to prevent infections and provide immediate protection from COVID-19 between close contacts. This is why we are excited to bring this data to health authorities with the goal of making the combination available to more people as soon as possible.”

The phase III, double-blind, placebo-controlled trial assessed the effect of casirivimab and imdevimab on individuals without SARS-CoV-2 antibodies or any COVID-19 symptoms, who lived in the same household as an individual who tested positive to SARS-CoV-2 within the prior four days. It included 1,505 people who were not infected with SARS-CoV-2 at baseline and received either one dose of casirivimab with imdevimab (1,200 mg) or placebo, administered as subcutaneous injections.

In addition, the multi-part study evaluated the antibody cocktail in a cohort of 204 recently infected asymptomatic patients randomised to receive either one dose of casirivimab and imdevimab (1,200 mg subcutaneous administration) or placebo. In this cohort, casirivimab and imdevimab reduced the overall risk of progressing to symptomatic COVID-19 by 31%.

Detailed results from the trial will be shared with regulatory authorities as soon as possible. Regeneron will share new data with the United States (U.S.) Food and Drug Administration (FDA) and Roche and Regeneron will continue to work with the European Medicines Agency (EMA) and other health authorities across the globe.

The antibody cocktail continues to be evaluated in clinical trials in multiple settings for COVID-19: in non-hospitalised and certain hospitalised patients, including the open-label RECOVERY trial of hospitalised patients in the UK. As of April 2021, more than 25,000 people have participated in clinical trials involving casirivimab and imdevimab.

In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working to overcome the pandemic.