Dupixent® (dupilumab) Late-breaking Pivotal Data Showing Significant Improvement in Eosinophilic Esophagitis Signs and Symptoms Presented for the First Time at Scientific Meetings
October 26, 2020 at 07:59 AM EDT
TARRYTOWN, N.Y. and PARIS, Oct. 26, 2020 /PRNewswire/ --
First Phase 3 trial in eosinophilic esophagitis (EoE) to show a biologic medicine significantly improved structural and histologic measures, while rapidly improving ability to swallow in patients 12 years and older
New late-breaking data show additional improvements in disease severity and extent, as well as normalized gene expression associated with type 2 inflammation
Results presented for the first time at virtual ACG 2020 and UEG Week 2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced additional positive results from Part A of a pivotal Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). As previously reported, the trial met both of its co-primary and all key secondary endpoints. New late-breaking data showing additional improvements in disease severity and extent at the microscopic level, as well as normalization of gene expression pattern associated with type 2 inflammation, were presented at the virtual American College of Gastroenterology (ACG) Annual Scientific Meeting and the United European Gastroenterology (UEG) Week Virtual 2020.
There are currently no FDA-approved medicines for EoE, a chronic and progressive inflammatory disease that damages the esophagus and prevents it from working properly. Over time, excessive type 2 inflammation may cause scarring and narrowing of the esophagus, making it difficult to swallow. EoE can affect a patient's ability to eat and cause food to become stuck after being swallowed (food impaction), which can lead to a medical emergency.
Previously announced results showed Dupixent improved symptomatic, structural and histologic measures of EoE. The use of Dupixent to treat EoE is investigational and has not been fully evaluated by any regulatory authority.
"The results from this trial show dupilumab significantly improved both patients' ability to swallow, as well as structural abnormalities in the esophagus, by targeting type 2 inflammation to help reverse tissue damage and scarring that usually worsens over time," said Evan S. Dellon, M.D., M.P.H., Professor of Gastroenterology and Hepatology at the University of North Carolina School of Medicine and principal investigator of the trial. "These results also demonstrate that eosinophilic esophagitis is a disease caused by factors beyond just the presence of elevated eosinophils. Dupilumab, which targets the activity of the cytokines IL-4 and IL-13 that drive type 2 inflammation, was able to show significant improvements in a broad range of clinical, anatomic, cellular and molecular measures."
Part A of the randomized, double-blind, placebo-controlled trial enrolled 81 patients aged 12 years and older with EoE, who were treated with Dupixent 300 mg weekly over a 24-week treatment period or placebo.
New results presented at virtual ACG 2020 and UEG Week 2020 showed patients treated with Dupixent experienced:
The trial demonstrated similar safety results to the well-established safety profile of Dupixent in its approved indications. For the 24-week treatment period, overall rates of adverse events were 86% for Dupixent and 82% for placebo. Adverse events that were more commonly observed with Dupixent included injection site reactions (n=15 for Dupixent, n=12 for placebo) and upper respiratory tract infections (n=11 for Dupixent, n=6 for placebo). There was one treatment discontinuation in the Dupixent group due to joint pain.
In September 2020, the FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients 12 years and older with EoE. Breakthrough Therapy designation is designed to expedite the development and review of drugs in the U.S. that target serious or life-threatening conditions. Drugs qualifying for this designation must show preliminary clinical evidence that it may demonstrate a substantial improvement on clinically significant endpoints over available therapies, or over placebo if there are no available therapies. In 2017, Dupixent was also granted Orphan Drug designation for the potential treatment of EoE. This is given to investigational medicines intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. and in which no adequate medicines have been developed and approved.
Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, that was invented using Regeneron's proprietary VelocImmune® technology. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and EoE.
About the Dupixent Eosinophilic Esophagitis Trial
The EoE trial is ongoing, with additional patients enrolling in Part B as well as patients continuing in a 28-week extended active treatment period (Part C) after completing either Part A or Part B. Part B of the trial is evaluating an additional Dupixent dosing regimen.
Dupixent was invented using Regeneron's VelocImmune® technology that utilizes a proprietary genetically-engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies. VelocImmune technology has been used to create multiple antibodies including Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab) and Kevzara® (sarilumab), which are approved in multiple countries around the world. Regeneron previously used these technologies to rapidly develop a treatment for Zaire ebolavirus infection, which is approved by the FDA, and to create a potentially preventative and therapeutic medicine for COVID-19 that was recently submitted to the FDA for an Emergency Use Authorization (EUA).
Dupilumab Development Program
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, including EoE (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), pediatric asthma (6 to 11 years of age, Phase 3), chronic obstructive pulmonary disease (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), and food and environmental allergies (Phase 2). These potential uses are investigational, and the safety and efficacy of dupilumab in these conditions have not been fully evaluated by any regulatory authority. Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
DUPIXENT is a prescription medicine used:
IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS
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:
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 or CRSwNP, and also have asthma. Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to come back.
DUPIXENT can cause serious side effects, including:
The most common side effects by indication are as follows:
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. Your healthcare provider will tell you how much DUPIXENT to inject and how often to inject it. DUPIXENT is an injection given under the skin (subcutaneous injection). If your healthcare provider decides that you or a caregiver can give DUPIXENT injections, you or your caregiver should receive training on the right way to prepare and inject DUPIXENT. Do not try to inject DUPIXENT until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that DUPIXENT be administered by or under supervision of an adult. In children younger than 12 years of age, DUPIXENT should be given by a caregiver.
Please see full Prescribing Information including Patient Information.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
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