Dupixent® (dupilumab) Demonstrates Improved Esophageal Function in Eosinophilic Esophagitis (EoE) Phase 4 Trial
Dupixent showed significant and clinically meaningful improvements in both esophageal distensibility as well as disease-related structural changes and inflammation in the esophagus in adult patients with EoE at week 24 compared to placebo, in results presented at DDW
These results reinforce the roles of IL-4 and IL-13, two of the key and central drivers of type 2 inflammation, in EoE
EoE is a chronic, progressive disease that causes scarring and narrowing of the esophagus, making it difficult to swallow food, with more pronounced damage increasing the risk for severe symptoms
TARRYTOWN, N.Y. and PARIS, May 05, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today presented results from the REMODEL Phase 4 trial demonstrating that Dupixent® (dupilumab) showed significant and clinically meaningful improvements in both esophageal distensibility (a measure of esophageal function) as well as disease-related structural changes to the esophagus compared to placebo in adults with eosinophilic esophagitis (EoE) at week 24. The results reinforce the previously established ability of Dupixent to address underlying inflammation and symptoms of this disease; Dupixent was the first and is still the only biologic and leading treatment indicated for EoE. The new data were shared today in a late-breaking oral presentation at the 2026 Digestive Disease Week (DDW) conference.
EoE is a chronic, progressive inflammatory disease associated with type 2 inflammation that damages the esophagus and prevents it from working properly. For people with EoE, swallowing even small amounts of food can lead to choking and become a painful and worrisome experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depression. In cases where EoE causes the esophagus to narrow, and the esophagus can no longer distend to support normal swallowing, forced and potentially painful dilation (physical expansion) of the esophagus may be needed. In severe cases, a feeding tube was historically the only available option to ensure proper caloric intake and adequate nutrition. However, Dupixent has dramatically changed the standard of care for this disease, improving quality of life for many patients.
"For patients who have eosinophilic esophagitis, if the disease remains untreated, it can progress to narrowing of the esophagus, more severe symptoms, such as food impaction, and the need for esophageal dilation," said Evan S. Dellon, M.D., M.P.H., Professor of Gastroenterology and Hepatology at the University of North Carolina School of Medicine and lead author of this study. "Dupixent showed a potential to modify the course of eosinophilic esophagitis – by improving esophageal size at just 6 months – the magnitude of this improvement corresponded to the benefit that could be seen from an esophageal dilation procedure. It also reduced hallmark endoscopic and histologic signs of disease, which further strengthens the evidence that type 2 inflammation plays an important role in the biology of this disease. The ongoing study will allow us to learn the even longer-term impact of Dupixent on the scarring and narrowing of the esophagus in EoE."
In the REMODEL Phase 4 trial, 69 adults with EoE were treated with Dupixent 300 mg (n=46) every week or placebo (n=23). At week 24, the results for Dupixent compared to placebo were:
- Improved esophageal distensibility (a measure of esophageal function): 1.28 mm improvement in esophageal distensibility plateau from baseline compared to -0.01 mm (1.30 mm placebo-corrected improvement; p<0.05), the primary endpoint. This represents a 9% improvement from baseline compared to 1% (8% placebo-corrected improvement; p<0.05), the key secondary endpoint. The esophageal distensibility plateau measures the ability of the esophagus to expand and allow food to be transported through the esophagus effectively, with higher numbers representing better esophageal function and lower numbers representing worse function.
- Reduced disease-related structural changes to the esophagus: 4.89-point reduction from baseline in abnormal endoscopic findings, as assessed by EREFS (a scale ranging from 0-18), evaluating a combination of esophageal edema (swelling), rings (bands of scar tissue that narrow the esophagus), exudates (white plaques indicative of inflammation), furrows (vertical grooves indicative of damaged lining) and strictures (narrowing), compared to 0.07-point increase (4.96-point placebo-corrected reduction; p<0.0001).
- Improved histological findings: 0.89-point and 0.80-point reductions from baseline in disease severity and extent, respectively, as assessed by the EoE-HSS grade and stage scores (both scales ranging from 0-3), measuring changes in eight cellular and tissue features of biopsy specimens at the microscopic level, compared to 0.18-point and 0.14-point reductions, respectively (0.71-point and 0.65-point placebo-corrected reductions, respectively; p<0.0001 for both).
- Increased histological remission: 59% of patients achieved peak esophageal intraepithelial counts of ≤6 eosinophils per high-power field (eos/hpf) compared to 4% (p<0.0001).
- Additionally, 78% of patients achieved peak esophageal intraepithelial counts of <15 eos/hpf, the diagnostic threshold for EoE, compared to 4% (nominal p<0.0001).
The safety results from the REMODEL trial were generally consistent with the known safety profile of Dupixent in EoE. The overall rates of adverse events (AEs) were 62% for Dupixent and 48% for placebo. AEs more commonly observed with Dupixent than placebo included injection site pain (9% vs. 4%) and headache (9% vs. 4%). There were no serious AEs in either treatment group.
About REMODEL
The ongoing REMODEL Phase 4, randomized, double-blind, placebo-controlled trial is evaluating the impact of Dupixent on esophageal remodeling and function in adults with EoE. During the 24-week, double-blind treatment period, all patients received Dupixent 300 mg every week or placebo. After week 24, patients entered an open-label treatment period and could either continue Dupixent or switch from placebo to Dupixent through week 128.
The primary endpoint assessed change from baseline at week 24 in esophageal distensibility plateau as measured by endoluminal functional lumen imaging probe (EndoFLIP), an innovative approach to assess esophageal function based on scarring and narrowing. Further assessments of esophageal distensibility are planned at week 76 and week 128 during the open-label treatment period. Esophageal distensibility plateau is reported in millimeters and represents how the esophagus expands in response to a small balloon being inflated at multiple points inside the esophagus. The distensibility plateau is the maximum esophageal diameter achieved at the narrowest point of the esophagus when further increases in balloon pressure do not meaningfully increase diameter. Higher numbers represent better esophageal function, and lower numbers represent worse function.
Secondary endpoints assessed at week 24 included:
- Percent change from baseline in esophageal distensibility plateau as measured by EndoFLIP, the key secondary endpoint.
- Change from baseline in EoE Endoscopic Reference Score (EoE-EREFS) on a 0-18 scale.
- Change from baseline in EoE Histology Scoring System (EoE-HSS) grade and stage scores, which measure changes in eight cellular and tissue features on 0-3 scales, respectively.
- Proportion of patients achieving histological disease remission (peak esophageal intraepithelial eosinophil count of ≤6 eosinophils [eos]/high power field [hpf]).
- Proportion of patients achieving the diagnostic threshold for EoE (peak esophageal intraepithelial eosinophil count of <15 eos/hpf).
About Dupixent
Dupixent, which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (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 the type 2 inflammation that plays 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 (CRSwNP), EoE, prurigo nodularis, chronic spontaneous urticaria (CSU), chronic obstructive pulmonary disease (COPD), bullous pemphigoid (BP) and allergic fungal rhinosinusitis (AFRS) in different age populations. More than 1,400,000 patients are being treated with Dupixent globally.1
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, Board co-Chair, 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 fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024.
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 12,000 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 lichen simplex chronicus. 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 AD 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 CRSwNP 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 EoE under 1 year of age, or who weigh less than 33 pounds (15 kg).
- to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with PN 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 COPD under 18 years of age.
- to treat adults and children 2 years of age and older with chronic spontaneous urticaria (CSU) who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if DUPIXENT is safe and effective in children with CSU under 2 years of age, or who weigh less than 11 pounds (5 kg).
- to treat adults with bullous pemphigoid (BP). It is not known if DUPIXENT is safe and effective in children with BP under 18 years of age.
- to treat adults and children 6 years of age and older with allergic fungal rhinosinusitis (AFRS), who have had surgery on their nose or sinuses in the past. It is not known if DUPIXENT is safe and effective in children with AFRS under 6 years of age.
DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine or to treat any other forms of hives (urticaria).
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.
- 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 AD, CRSwNP, EoE, PN, COPD, CSU, BP, or AFRS 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, including skin 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, skin rash, including rash that looks like a bullseye, painful red or blue bumps under the skin, or red pus-filled spots on the skin, general ill feeling, itching, swollen lymph nodes, nausea or vomiting, joint pain, or cramps in your stomach area.
- Eye problems. Tell your healthcare provider right away 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. Tell your healthcare provider right away if you get: rash, chest pain, worsening shortness of breath, brown or dark colored urine, persistent fever, or a feeling of pins and needles or numbness of your arms or legs.
- Psoriasis. This can happen in people with atopic dermatitis and asthma who receive DUPIXENT. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination if needed.
- 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:
- Eczema: injection site reactions; eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, dry eye, and blurred vision; 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 problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, and blurred vision; high count of a certain white blood cell (eosinophilia), stomach problems (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 problems, including eye and eyelid inflammation, redness, swelling, itching, and 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; stomach problems (gastritis); joint pain (arthralgia); toothache; headache; and urinary tract infection.
- Chronic Spontaneous Urticaria: injection site reactions.
- Bullous Pemphigoid: joint pain (arthralgia); eye problems, including eye and eyelid inflammation, redness, swelling, itching, and blurred vision; and herpes virus infections.
- Allergic Fungal Rhinosinusitis: injection site reactions; eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, and blurred vision; high count of a certain white blood cell (eosinophilia); stomach problems (gastritis); joint pain (arthralgia); trouble sleeping (insomnia); and toothache.
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
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
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