Dupixent late-breaking positive phase 3 data in chronic spontaneous urticaria to be presented at ACAAI

• Dupixent significantly reduced itch and hive activity from baseline; 41% of patients achieved well-controlled disease status
• Confirmatory data to support US regulatory resubmission by year-end; if approved, Dupixent would be the first new targeted treatment for people living with chronic spontaneous urticaria in more than 10 years
• More than 300,000 people in the US suffer from chronic spontaneous urticaria that is inadequately controlled by antihistamines

Paris and Tarrytown, NY, October 24, 2024. Positive data from the phase 3 LIBERTY-CUPID Study C evaluating the investigational use of Dupixent (dupilumab) in biologic-naive patients with uncontrolled chronic spontaneous urticaria (CSU) who receive background therapy with antihistamines will be presented in a late-breaking oral presentation at the American College of Allergy, Asthma and Immunology (ACAAI) 2024 Annual Scientific Meeting in Boston, Massachusetts. Results showed treatment with Dupixent significantly reduced itch and urticaria activity (itch and hive) scores from baseline, and a higher proportion of patients achieved well-controlled disease status, compared to placebo.

Thomas B. Casale, M.D.

Professor, Internal Medicine, Morsani College of Medicine at the University of South Florida, USA

“Chronic spontaneous urticaria is an inflammatory skin condition that affects patients with unpredictable episodes of intense itching and hives, often severely impacting their daily lives. These data confirm results seen in the previous Study A and reinforce the potential of Dupixent to significantly alleviate symptoms for patients, helping them to better control this challenging disease.”

Study C enrolled 151 children and adults who were randomized to receive Dupixent (n=74) or placebo (n=77) added to standard-of-care histamine-1 (H1) antihistamines. At 24 weeks, Dupixent demonstrated significant improvements compared to placebo on:

• Itch severity score (8.64- vs. 6.10-point reduction from baseline; p=0.02)
• Urticaria (itch and hive) activity score (15.86- vs. 11.21-point reduction from baseline; p=0.02)
• Well-controlled disease status (urticaria activity score ≤6; 41% vs. 23%; p=0.005)
• Complete response (urticaria activity score=0; 30% vs. 18%; p=0.02)

The safety results in Study C were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. Overall rates of treatment emergent adverse events (AEs) were 53% for both Dupixent and placebo. AEs more commonly observed with Dupixent (≥5%) compared to placebo included injection site reactions (12% vs. 4%), accidental overdose (7% vs. 3%) and COVID-19 infection (8% vs. 5%).

Dupixent has been approved for CSU in Japan, the United Arab Emirates (UAE) and is also under regulatory review in the European Union based on earlier trial readouts. Outside of Japan and the UAE, the safety and efficacy of Dupixent for CSU has not been fully evaluated by any regulatory authority.

About CSU

CSU is a chronic inflammatory skin disease driven in part by type-2 inflammation, which causes sudden and debilitating hives and persistent itch. CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria. However, the disease remains uncontrolled despite antihistamine treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life. More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines.

About the Dupixent phase 3 CSU program (LIBERTY-CUPID)

The LIBERTY-CUPID Phase 3 study program evaluating Dupixent for CSU consists of Study A, Study B, and Study C.

Study C was a randomized, double-blind, placebo-controlled clinical study that evaluated the efficacy and safety of Dupixent as an add-on to standard-of-care antihistamines compared to antihistamines alone in 151 patients aged six years and older with CSU who remained symptomatic despite antihistamine use and were not previously treated with omalizumab (i.e., biologic-naïve). The primary endpoint assessed the change from baseline in itch at 24 weeks (measured by the weekly itch severity score [ISS7], 0-21 scale). Secondary endpoints at 24 weeks, measured by the weekly urticaria activity score (UAS7) included the change from baseline in itch and hives (UAS7, 0-42 scale), proportion of patients achieving well-controlled disease status (UAS7 ≤6), and complete response (UAS7=0).

About Dupixent

Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type-2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of type-2 inflammation that play a major role in multiple related and often co-morbid diseases.

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different age populations. More than 1,000,000 patients are being treated with Dupixent globally.

Dupilumab development program

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type-2 inflammation.

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven in part by type-2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

About Regeneron

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite^®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center^® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

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