Regeneron (REGN) Announces ATS 2021 Breaking News Session to Feature Pivotal Data on REGEN-COV and Dupixent

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that positive Phase 3 data from trials evaluating two Regeneron medicines will be featured at the 2021 American Thoracic Society International Conference (ATS 2021) in the Breaking News: Clinical Trial Results in Pulmonary Medicine Scientific Symposium on May 17, 2021. The data selected for presentation in this session represent late-breaking information on leading clinical trials in pulmonary and critical care medicine. It includes positive results from two Regeneron pivotal Phase 3 trials, the first evaluating REGEN–COV™ (casirivimab with imdevimab) in high-risk non-hospitalized patients (outpatients) with mild-to-moderate COVID-19, and the second evaluating Dupixent® (dupilumab) in children as young as 6 years with uncontrolled moderate-to-severe asthma. These uses for both medicines are investigational.

"We work every day to push the boundaries of science to improve patient lives, and are pleased to see two of our medicines recognized at ATS as leading data that could potentially impact the COVID-19 and asthma landscape," said David Weinreich, M.D., Executive Vice President and Head of Global Clinical Development at Regeneron. "We pride ourselves on quickly and consistently translating science to medicine, and as part of this process, it is particularly important to present our data in peer-reviewed settings. We are moving rapidly to publish these significant results in peer-reviewed journals."

REGEN–COV is an investigational antibody cocktail authorized for emergency use in the U.S. for patients with mild-to-moderate COVID-19 who are at high-risk of severe disease or hospitalization, and is strongly recommended by the National Institute of Health COVID-19 Treatments Guidelines for these patients. REGEN–COV continues to be studied in the outpatient (symptomatic and asymptomatic infections), prevention and certain hospitalized COVID-19 patient settings.

In addition to the pivotal Phase 3 results in children as young as 6 years, Dupixent data being presented at ATS 2021 also include results from a two-year open-label extension trial on the ability of Dupixent to reduce and eliminate long-term oral corticosteroid use in adults and simultaneously improve patient-reported, health-related quality of life outcomes in adults and adolescents with asthma. Regeneron will also present data from the largest clinical trial to date demonstrating rapid and significant symptom improvement in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This includes results across several key measures including sense of smell, and in adults with or without coexisting respiratory diseases such as asthma, allergic rhinitis and aspirin-exacerbated respiratory disease. Safety results from these trials were generally consistent with the known safety profile of Dupixent in its approved indications.

Presentations at ATS 2021 (May 14-19) B007: Breaking News: Clinical Trial Results in Pulmonary Medicine Scientific SymposiumMay 17, 2021 | 10:00 am-11:30 am EDT

• Casirivimab with Imdevimab, a Cocktail of Two Antibodies Against SARS-CoV-2, in the Outpatient Setting: Phase 3 Efficacy and Safety Results, Julie Philley
• Efficacy and Safety of Dupilumab in Children With Uncontrolled Moderate-to-Severe Asthma, Leonard Bacharier

Dupixent Data PresentationsData evaluating Dupixent efficacy, safety, and long-term clinical and health-related quality of life outcomes will be also presented:

Adult and adolescent asthma, including long-term outcomes

• Abstract #A1204: Dupilumab Efficacy and Safety in Children With Uncontrolled Moderate-to-Severe Asthma: The Phase 3 VOYAGE Study, Leonard Bacharier
  • Oral Presentation Session: D007 Advances in Asthma Therapies, Wednesday, May 19, 10:00 am-11:30 am EDT
• Abstract #A1201: Long-Term Dupilumab Treatment in Moderate-to-Severe Asthma With Type 2 Inflammation: Open Label LIBERTY ASTHMA TRAVERSE Study, Michael Wechsler
  • Oral Presentation Session: D007 Advances in Asthma Therapies, Wednesday, May 19, 10:00 am-11:30 am EDT
• Abstract #A1441: Assessment of Long-Term Maintenance of OCS Reduction and Efficacy in the Dupilumab LIBERTY ASTHMA TRAVERSE Extension Study, Lawrence Sher
• Abstract #A1452: Dupilumab Shows Sustained Efficacy and Improvements in Asthma Control and Health-Related Quality of Life in Patients With Moderate-to-Severe Asthma: LIBERTY ASTHMA TRAVERSE, Michael Wechsler
• Abstract #A1446: Dupilumab Efficacy in Patients With Moderate-to-Severe Type 2 Asthma With and Without Elevated Blood Neutrophils, Eugene Bleecker
• Abstract #A1460: Long-Term 3-Year Efficacy of Dupilumab in QUEST Patients Enrolled in LIBERTY ASTHMA TRAVERSE, Albert Papi
• Abstract #A1443: Long-term Exacerbations and Lung Function Assessment in LIBERTY ASTHMA TRAVERSE Stratified by Lung Function Improvements at the End of Parent Study, Nicola Hanania
• Abstract #A1444: Dupilumab Provides Rapid and Sustained Exacerbation Protection in Patients With Uncontrolled, Moderate-to-Severe Type 2 Inflammatory Asthma Enrolled in the LIBERTY ASTHMA QUEST Study, Jonathan Corren

Adult CRSwNP efficacy and safety

• Abstract #A1340: Efficacy of Dupilumab in Patients With Chronic Rhinosinusitis With Nasal Polyps and Allergic Rhinitis, Anju T. Peters
• Abstract #A1345: Rapid and Sustained Effects of Dupilumab in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps: Analysis of the SINUS-24 and SINUS-52 Phase 3 Trials, Peter W. Hellings
• Abstract #A1343: Association between Dupilumab Effect on Nasal Polyp Score and Biomarkers of Type 2 Inflammation in Patients With Chronic Rhinosinusitis With Nasal Polyps in the Phase 3 SINUS-24 and SINUS-52 Trials, Claus Bachert
• Abstract #A1341: Dupilumab Provides Early and Durable Alleviation of Symptoms in Patients with Chronic Rhinosinusitis with Nasal Polyps: Results from the SINUS-24 and SINUS-52 Phase 3 Trials, Philippe Gevaert

Real-world data in asthma

• Abstract #A1449: The RAPID Registry: A Global Real-World Cohort of Patients Receiving Dupilumab for the Treatment of Moderate-to-Severe Asthma, Neal Jain

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