Phase 3 Data Show REGEN-COV Reduces Hospitalization or Death Risk by 70% in Non-Hospitalized COVID-19 Patients Amid Global Cases Surpassing 164 Million

May 18, 2021 News /BioonBIOON/ --Currently, the overseas COVID-19 epidemic continues to spread rapidly. According to Baidu's 《Real-time Novel Coronavirus Pneumonia EpidemicBig DataReport》，as of 15:00 on May 18, 2021, the global cumulative number of confirmed cases exceeded160 million(164.28 million) cases, deaths exceeding3.4 million cases。

Recently, Roche's partner Regeneron at the 2021 American Thoracic Society InternationalConferenceAt ATS 2021, detailed results of the pivotal Phase 3 trial for the antibody cocktail therapy REGEN-COV (casirivimab and imdevimab) were presented. Data showed that, compared with placebo, REGEN-COV significantly reduced the risk of hospitalization or death by 70% in non-hospitalized COVID-19 patients (outpatients), shortened the time to symptom resolution by 4 days, and significantly reduced viral load.. In this study, the efficacy of the two doses (1200 mg and 2400 mg) was similar. Currently, in the United StatesFDAThe application to add a 1,200 mg dose to the Emergency Use Authorization (EUA) is under review.

Julie Philley, an investigator for the trial and Chair of Internal Medicine at the University of Texas Health Science Center, stated: “Although the COVID-19 vaccination rate continues to rise, many people are still beingDiagnosistested positive for COVID-19. For patients due toAsthmaor those at higher risk for severe COVID-19 due to underlying medical conditions such as chronic obstructive pulmonary disease, will be able to benefit from REGEN-COV. This Phase 3 trial demonstrated that REGEN-COV can help patients avoid hospitalization or even death, while accelerating recovery time. These results add to a growing body of clinical evidence, real-world experience, and strong recommendations from the National Institutes of Health (NIH) COVID-19 Treatment Guidelines, all of which collectively underscore the urgent need to ensure that all eligible patients receive treatment.”

This Phase 3, randomized, double-blind, placebo-controlled trial evaluated REGEN-COV in 4,567 high-risk outpatients with COVID-19. Two doses of REGEN-COV (1,200 mg and 2,400 mg) were evaluated in the trial. Among these, the 2,400 mg dose has received U.S.FDAApproved, the 1,200 mg dose is under review. All patients evaluated for efficacy had at least one severe COVID-19 risk factor, such as chronic lung disease (includingAsthma), obesity, cardiovascular disease, or age ≥ 50 years.

In March 2021, Roche and Regeneron announced positive top-line results from the trial, showing that REGEN-COV met the primary endpoint and all secondary endpoints, with similar efficacy between the two doses. Detailed data presented at this meeting showed that patients treated with 1200 mg or 2400 mg of REGEN-COV experienced:

— Compared with placebo, by day 29,The risk of hospitalization or death was reduced by 70%(p=0.0024) and 71% (p<0.0001).

——Time to symptom resolution shortened by 4 days, the median was 10 days in the two REGEN-COV groups and 14 days in the placebo group.

— Compared with placebo,Significant reduction in viral load within 7 days0.71 log10 copies/mL and 0.86 log10 copies/mL (both p<0.0001).

——As of Day 169, safety was assessed in 5,531 patients, and the safety profile was consistent with previously reported data. Serious adverse events (SAEs) were primarily related to COVID-19, occurring in 1.1% of patients in the 1200 mg group, 1.3% in the 2400 mg group, and 4.0% in the placebo group. One death occurred in the 1200 mg group (n=827), one in the 2400 mg group (n=1849), and five in the placebo group (n=1843).

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

REGEN-COV is an antibody cocktail therapy comprising two antibodies that target two distinct, non-overlapping epitopes within the receptor-binding domain of the SARS-CoV-2 spike protein. Acting synergistically, they reduce the risk of viral mutational escape. Non-human primate data 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.In August 2020, Roche and Regeneron entered into a strategic collaboration to develop, manufacture, and distribute REGEN-COV globally. The medication is expected to provide a much-needed treatment option for patients who have already developed symptoms of COVID-19, and has the potential to prevent infection in high-risk individuals exposed to the virus, thereby slowing the spread of the global pandemic.

November 2020, United StatesFDAEmergency Use Authorization (EUA) has been granted for REGEN-COV for the treatment of high-risk patients 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 by direct viral testing and are at high risk of progression to severe COVID-19 and/or hospitalization. The U.S. NIH COVID-19 Treatment Guidelines strongly recommend the use of REGEN-COV in these patients. Additionally, studies have demonstrated that REGEN-COV retains in vitro activity against major SARS-CoV-2 variants of concern anticipated to circulate in the United States. REGEN-COV is administered intravenously (IV), with an infusion time as short as 20 minutes.

In the European Union, in January 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a scientific opinion pursuant to 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 the granting of a formal marketing authorization, EU Member States may consider the CHMP’s scientific opinion when making decisions on the use of the medicinal product at the national level. The review conducted under Article 5(3) was carried out independently but runs concurrently with the EMA’s ongoing rolling review of REGEN-COV.

Currently, REGEN-COV will continue to be inOutpatient (symptomatic and asymptomatic infection), prevention, certain hospitalized COVID-19 patientsevaluated in. In April 2021, Regeneron and Roche announced preliminary positive results from a Phase 3 study (REGN-COV 206), which evaluated the ability of REGEN-COV to reduce the risk and burden of COVID-19 infection among household contacts of individuals infected with the novel coronavirus (SARS-CoV-2).

The results showed that the study met its primary and key secondary endpoints. Data indicate that,Among individuals who were uninfected at trial entry, subcutaneous administration of REGEN-COV reduced the risk of symptomatic infection by 81%.. In addition,In individuals who developed symptomatic infection despite REGEN-COV treatment, symptoms resolved on average within 1 week, compared to 3 weeks in the placebo group.。No new or serious safety signals were observed in the study. (Bioon.com)

Source: Phase 3 Data Presented at ATS 2021 Show REGEN-COV™ (casirivimab with imdevimab) Reduced Risk of Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patients