Roche/Regeneron's Antibody Cocktail REGEN-COV Reduces Symptomatic COVID-19 Infection Risk by 81% in High-Risk Individuals Through Passive Immunity

April 13, 2021 /BioonBIOON/ -- Currently, the COVID-19 epidemic overseas is still spreading rapidly. According to Baidu's "Real-time Epidemic Situation of Novel Coronavirus Pneumonia"Big DataReport, as of 00:00 on April 13, 2021, the global cumulative confirmed cases exceeded 130 million (136.77 million), with over 2.95 million deaths.

Recently, Roche and its partner Regeneron confirmed the positive results of the Phase 3 REGN-COV 206 trial. This trial evaluated the ability of the antibody cocktail therapy REGEN-COV (casirivimab and imdevimab) to reduce the risk and burden of COVID-19 infection among household contacts of individuals infected with the novel coronavirus (SARS-CoV-2). The trial was conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). In the trial, individuals at high risk of infection were randomly assigned to receive passive immunization with either REGEN-COV (1200 mg, subcutaneous injection) or a placebo.

The results showed that the study met its primary and key secondary endpoints. The data indicated that subcutaneous injection of REGEN-COV reduced the risk of symptomatic infection by 81% among individuals who were uninfected at trial entry. Furthermore, individuals who received REGEN-COV but still experienced symptomatic infection had an average symptom resolution time of one week, compared to three weeks for those receiving placebo. No new or serious safety signals were observed in the study.

Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche, stated: “Today’s data confirm the potential dual value of REGEN-COV (casirivimab and imdevimab) as a subcutaneous injection option in reducing household transmission of COVID-19 and alleviating the disease burden among infected individuals. Although vaccination rates are rising globally, preventing infection and providing immediate protection against COVID-19 for close contacts remain critical unmet needs. This is why we are pleased to submit these data to regulatory authorities, with the aim of making this combination therapy available to more people as soon as possible.”

Key Results of the Non-Infected Individual Prevention Cohort

REGN-COV 206 was a randomized, double-blind, placebo-controlled trial evaluating the effect of REGEN-COV on individuals without SARS-CoV-2 antibodies or any symptoms of COVID-19 who lived in the same household as an individual who had tested positive for SARS-CoV-2 within the previous 4 days. The study included 1,505 individuals who were not infected with SARS-CoV-2 at baseline and who received a single subcutaneous injection of REGEN-COV (1200 mg) or placebo.

Furthermore, this multi-part study also evaluated REGEN-COV in 204 recently infected asymptomatic patients. These patients were randomized into two groups, one receiving a single dose of REGEN-COV (1,200 mg subcutaneously) or placebo. In this cohort, REGEN-COV reduced the overall risk of developing symptomatic COVID-19 by 31%.

In terms of safety, adverse events (AEs) occurred in 20% (n=265/1311) of subjects in the REGEN-COV group and 29% (n=379/1306) of subjects in the placebo group. Serious adverse events occurred in 1% (n=10) of subjects in the REGEN-COV group and 1% (n=15) of subjects in the placebo group. During the 29-day efficacy evaluation period, 0 subjects in the REGEN-COV group and 4 subjects in the placebo group were hospitalized or visited the emergency room due to COVID-19. Injection site reactions, all Grade 1–2, occurred in 4% (n=55) of subjects in the REGEN-COV group and 2% (n=19) of subjects in the placebo group. No subjects withdrew from the trial due to adverse events in either group. There were no deaths attributed to COVID-19 or the study drug during the trial (2 in the REGEN-COV group and 2 in the placebo group).

The detailed results of this study will be shared with regulatory authorities as soon as possible. Regeneron will work with the U.S.FDASharing New Data, Roche and Regeneron Will Continue to Collaborate with the European Medicines Agency (EMA) and Other Regulatory Authorities Worldwide.

The antibody cocktail REGEN-COV will continue to be available inClinical Trialevaluated in various settings for combating COVID-19: in non-hospitalized patients and certain hospitalized patients, including the open-label RECOVERY trial involving hospitalized patients in the UK. As of April 2021, more than 25,000Ginsengwith REGEN-COVClinical Trials。

REGN-COV (Image source: maroc-hebdo.press.ma)

REGEN-COV is a cocktail therapy composed of two antibodies that target two distinct, non-overlapping epitopes within the receptor-binding domain of the SARS-CoV-2 spike protein. These antibodies act synergistically to reduce the risk of viral escape due to mutation. Data from non-human primate studies demonstrate that REGEN-COV can prevent SARS-CoV-2 infection and treat infected animals by accelerating viral clearance.

REGEN-COV was developed for the treatment and prevention of COVID-19 infection. Currently, REGEN-COV is being evaluated in multiple clinical studies, including a Phase 2/3 trial assessing its efficacy in treating specific hospitalized and non-hospitalized patients with COVID-19.Clinical Trial, the open-label Phase 3 RECOVERY trial conducted in hospitalized patients in the United Kingdom, and the Phase 3 prevention trial conducted among household contacts of COVID-19 patients.

In August 2020, Roche announced a strategic collaboration with Regeneron to develop, manufacture, and distribute REGEN-COV globally. This therapy was developed for the treatment and prevention of COVID-19 infection, aiming to provide an urgently needed treatment option for patients who have already developed symptoms of COVID-19, and has the potential to prevent infection in high-risk populations exposed to the virus, thereby slowing the spread of the global pandemic.

November 2020, United StatesFDAGranting of Emergency Use Authorization (EUA) for REGEN-COV for the treatment of high-risk individuals recently diagnosed with mild to moderate COVID-19, specifically: pediatric and adult patients aged ≥12 years and weighing ≥40 kg who have tested positive for SARS-CoV-2 via direct viral testing and are at high risk for progression to severe COVID-19 and/or hospitalization.

In January 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a scientific opinion under Article 5(3) of Regulation (EC) No 726/2004, supporting the use of REGEN-COV as a treatment option for patients with confirmed COVID-19 who do not require supplemental oxygen and are at high risk of progressing to severe COVID-19. Prior to formal authorization, EU Member States may consider the CHMP’s scientific opinion when making decisions on the use of the medicine at the national level. The review conducted under Article 5(3) was carried out separately but concurrently with the ongoing rolling review of REGEN-COV by the EMA. (Bioon.com)

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