Dupixent® (dupilumab) Late-Breaking Positive Phase 3 Data in Chronic Spontaneous Urticaria to Be Presented at ACAAI
Regeneron Pharmaceuticals and Sanofi presented positive Phase 3 data for Dupixent in treating chronic spontaneous urticaria (CSU). The LIBERTY-CUPID Study C showed significant improvements in patients receiving Dupixent with antihistamines compared to placebo. Key results at 24 weeks included a 8.64-point reduction in itch severity score and 41% of patients achieving well-controlled disease status. The study involved 151 biologic-naïve patients, with 74 receiving Dupixent and 77 receiving placebo. Safety results aligned with Dupixent's known profile, with 53% experiencing treatment emergent adverse events in both groups. The companies plan to submit for U.S. regulatory approval by year-end.
Regeneron Pharmaceuticals e Sanofi hanno presentato dati positivi della Fase 3 per Dupixent nel trattamento dell'orticaria spontanea cronica (CSU). Lo Studio LIBERTY-CUPID C ha mostrato miglioramenti significativi nei pazienti trattati con Dupixent e antistaminici rispetto al placebo. I risultati chiave a 24 settimane hanno incluso una riduzione di 8,64 punti nel punteggio di gravità del prurito e il 41% dei pazienti ha raggiunto uno stato di malattia ben controllato. Lo studio ha coinvolto 151 pazienti naive a biologici, di cui 74 hanno ricevuto Dupixent e 77 placebo. I risultati di sicurezza si sono allineati con il profilo noto di Dupixent, con il 53% che ha sperimentato eventi avversi emergenti dal trattamento in entrambi i gruppi. Le aziende pianificano di presentare domanda di approvazione regolatoria negli Stati Uniti entro la fine dell'anno.
Regeneron Pharmaceuticals y Sanofi presentaron datos positivos de la Fase 3 para Dupixent en el tratamiento de la urticaria espontánea crónica (CSU). El Estudio LIBERTY-CUPID C mostró mejoras significativas en los pacientes que recibieron Dupixent junto con antihistamínicos en comparación con el placebo. Los resultados clave a las 24 semanas incluyeron una reducción de 8.64 puntos en la puntuación de gravedad de la picazón y el 41% de los pacientes alcanzaron un estado de enfermedad bien controlado. El estudio involucró a 151 pacientes naïve a biológicos, de los cuales 74 recibieron Dupixent y 77 placebo. Los resultados de seguridad se alinearon con el perfil conocido de Dupixent, con el 53% experimentando eventos adversos emergentes del tratamiento en ambos grupos. Las empresas planean solicitar la aprobación regulatoria en EE. UU. para fin de año.
레제너론 제약과 사노피는 만성 자발성 두드러기(CSU) 치료를 위한 듀픽센트의 3상 긍정적인 데이터를 발표했습니다. LIBERTY-CUPID C 연구에서는 항히스타민제와 함께 듀픽센트를 투여받은 환자들이 위약군에 비해 상당한 개선을 보였습니다. 24주째 주요 결과로는 가려움증 심각도 점수가 8.64점 감소하고, 환자의 41%가 질병 통제 상태를 달성했습니다. 연구는 생물학적 요법에 대해 경험이 없는 151명의 환자를 포함했으며, 이 중 74명이 듀픽센트를, 77명이 위약을 받았습니다. 안전성 결과는 듀픽센트의 알려진 프로필과 일치하였으며, 두 그룹 모두에서 53%가 치료로 인해 발생한 부작용을 경험했습니다. 두 회사는 연말까지 미국의 규제 승인을 신청할 계획입니다.
Regeneron Pharmaceuticals et Sanofi ont présenté des données positives de Phase 3 pour Dupixent dans le traitement de l'urticaire spontanée chronique (CSU). L'étude LIBERTY-CUPID C a montré des améliorations significatives chez les patients recevant Dupixent avec des antihistaminiques par rapport au placebo. Les résultats clés à 24 semaines incluaient une réduction de 8,64 points dans le score de gravité du démangeaison et 41 % des patients atteignant un état de maladie bien contrôlé. L'étude a impliqué 151 patients naïfs aux biologiques, dont 74 ont reçu Dupixent et 77 un placebo. Les résultats de sécurité étaient conformes au profil connu de Dupixent, avec 53 % d'événements indésirables émergents du traitement dans les deux groupes. Les entreprises prévoient de soumettre leur demande d'approbation réglementaire aux États-Unis d'ici la fin de l'année.
Regeneron Pharmaceuticals und Sanofi haben positive Phase-3-Daten für Dupixent zur Behandlung der chronischen spontanen Urtikaria (CSU) vorgestellt. Die LIBERTY-CUPID-Studie C zeigte signifikante Verbesserungen bei Patienten, die Dupixent zusammen mit Antihistaminika im Vergleich zu Placebo erhielten. Zu den wichtigsten Ergebnissen nach 24 Wochen gehörten eine Reduktion von 8,64 Punkten im Juckreizschweregrad und 41 % der Patienten erreichten einen gut kontrollierten Krankheitsstatus. Die Studie umfasste 151 biologisch naive Patienten, von denen 74 Dupixent erhielten und 77 Placebo. Die Sicherheitsresultate entsprachen dem bekannten Profil von Dupixent, wobei 53 % in beiden Gruppen behandlungsbedingte unerwünschte Ereignisse erlebten. Die Unternehmen planen, bis Ende des Jahres einen Antrag auf Zulassung in den USA einzureichen.
- Significant reduction in itch severity score (8.64 vs 6.10-point reduction)
- 41% of patients achieved well-controlled disease status vs 23% for placebo
- 30% of patients achieved complete response vs 18% for placebo
- Already approved in Japan and UAE for CSU treatment
- 53% of patients experienced treatment emergent adverse events
- Higher rates of injection site reactions (12% vs 4%) compared to placebo
- Increased COVID-19 infection rates (8% vs 5%) compared to placebo
Insights
The Phase 3 LIBERTY-CUPID Study C results represent a significant milestone for Regeneron's Dupixent in treating chronic spontaneous urticaria (CSU). The data shows 41% of patients achieved well-controlled disease status and 30% achieved complete response, demonstrating strong efficacy in a condition with treatment options.
The market opportunity is substantial with over 300,000 patients in the U.S. alone suffering from antihistamine-resistant CSU. With planned regulatory resubmission by year-end and existing approvals in Japan and UAE, Dupixent could capture significant market share as the first new targeted treatment for CSU in over a decade.
The safety profile aligns with existing approved indications, strengthening the likelihood of regulatory approval. This expansion would add to Dupixent's growing portfolio of inflammatory conditions, potentially driving additional revenue growth for Regeneron and Sanofi's blockbuster drug.
Dupixent significantly reduced itch and hive activity from baseline;
Confirmatory data to support U.S. 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 U.S. suffer from chronic spontaneous urticaria that is inadequately controlled by antihistamines
TARRYTOWN, N.Y. and PARIS, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi will present positive data from the Phase 3 LIBERTY-CUPID Study C evaluating the investigational use of Dupixent® (dupilumab) in biologic-naïve patients with uncontrolled chronic spontaneous urticaria (CSU) who receive background therapy with antihistamines. 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. The data are being shared in a late-breaking oral presentation at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting in Boston, Massachusetts.
“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," said Thomas B. Casale, M.D., Professor, Internal Medicine, Morsani College of Medicine at the University of South Florida, USA. "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
Dupixent has been approved for CSU in Japan and 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 Chronic Spontaneous Urticaria (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 U.S. suffer from CSU that is inadequately controlled by antihistamines.
About the Dupixent Phase 3 CSU Program (LIBERTY-CUPID)
The LIBERTY-CUPID Phase 3 program evaluating Dupixent for CSU consists of Study A, Study B and Study C. Study C was a randomized, double-blind, placebo-controlled clinical trial 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, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 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 trials, establishing that IL-4 and IL-13 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, CSU, and chronic obstructive pulmonary disease in different age populations. More than 1,000,000 patients are being treated with Dupixent globally.
About Regeneron’s VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent, Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz™ (pozelimab-bbfg).
Dupilumab Development Program
Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, 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.
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 months of age.
- with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age.
- with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyps under 12 years of age.
- to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33
pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with eosinophilic esophagitis under 1 year of age, or who weigh less than 33pounds (15 kg). - to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with prurigo nodularis under 18 years of age.
- with other medicines for the maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to your COPD). DUPIXENT is used to reduce the number of flare-ups (the worsening of your COPD symptoms for several days) and can improve your breathing. It is not known if DUPIXENT is safe and effective in children with chronic obstructive pulmonary disease under 18 years of age.
DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine.
IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:
- have eye problems.
- have a parasitic (helminth) infection.
- are scheduled to receive any vaccinations. You should not receive a “live vaccine” right before and during treatment with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
- A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/.
- are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, or chronic obstructive pulmonary disease and also have asthma. Do not change or stop your other medicines, including corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by those medicines to come back.
DUPIXENT can cause serious side effects, including:
- Allergic reactions. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, joint pain, general ill feeling, itching, skin rash, swollen lymph nodes, nausea or vomiting, or cramps in your stomach-area.
- Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed.
- Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by DUPIXENT. Tell your healthcare provider right away if you have: rash, chest pain, worsening shortness of breath, a feeling of pins and needles or numbness of your arms or legs, or persistent fever.
- Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms.
The most common side effects include:
- Eczema: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, dry eye, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia).
- Asthma: injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections.
- Chronic Rhinosinusitis with Nasal Polyps: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, high count of a certain white blood cell (eosinophilia), gastritis, joint pain (arthralgia), trouble sleeping (insomnia), and toothache.
- Eosinophilic Esophagitis: injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia).
- Prurigo Nodularis: eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea.
- Chronic Obstructive Pulmonary Disease: injection site reactions, common cold symptoms (nasopharyngitis), high count of a certain white blood cell (eosinophilia), viral infection, back pain, inflammation inside the nose (rhinitis), diarrhea, gastritis, joint pain (arthralgia), toothache, headache, and urinary tract infection.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed by your healthcare provider. It’s an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it’s recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.
Please see accompanying full Prescribing Information including Patient Information.
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.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
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FAQ
What were the main results of Regeneron's (REGN) Phase 3 LIBERTY-CUPID Study C for Dupixent?
How many patients were involved in Regeneron's (REGN) Dupixent CSU Phase 3 trial?
What are the side effects reported in Regeneron's (REGN) Dupixent CSU trial?
When will Regeneron (REGN) submit Dupixent for U.S. approval in CSU?
