SECOND DUPIXENT(DUPILUMAB) PHASE 3 EOSINOPHILIC ESOPHAGITIS TRIAL TO DEMONSTRATE SIGNIFICANT DISEASE IMPROVEMENTS, UNDERSCORING ROLE OF TYPE 2 INFLAMMATION IN THIS COMPLEX DISEASE
Regeneron Pharmaceuticals, Inc.?(NASDAQ: REGN) and Sanofi today announced results from a second Phase 3 trial assessing the investigational use of Dupixent??(dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). The trial met its co-primary endpoints in patients taking Dupixent 300 mg weekly, showing significant improvements in clinical (Dysphagia Symptom Questionnaire) and histologic disease measures compared to placebo. In?September 2020, the?U.S. Food and Drug Administration?(FDA) granted Breakthrough Therapy designation to Dupixent for the treatment of patients 12 years and older with EoE.
"This trial gives insight into how terrible this disease can be, with more than a third of patients having previously required invasive endoscopic dilations that can temporarily reduce symptoms but carry the risk of rupturing the esophagus," said?George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron and a principal inventor of Dupixent. "Dupixent, which blocks the IL-4 and IL-13 pathways, has now shown compelling results across a spectrum of diseases where there has been great unmet need. In fact, our positive Phase 3 data in six different diseases help confirm our early hypothesis that IL-4 and IL-13 are the main drivers of allergic or type 2 inflammation and disease, whether manifested in the gastrointestinal tract as eosinophilic esophagitis, the respiratory tract as asthma or nasal polyps, or the skin as atopic dermatitis, chronic spontaneous urticaria, or prurigo nodularis."
EoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly. At times,?swallowing the smallest quantity of food or taking a sip of water can be a painful and worrisome choking experience. Those with EoE live with anxiety and frustration from having a constantly evolving list of trigger foods?to avoid. Dilation (physical expansion) of the esophagus, which is used to address narrowing, is often painful. In severe cases, a feeding tube is the only option to ensure proper caloric intake and weight gain. People with EoE may have poor?quality of life and are more likely to experience depression, especially as they age, than people without EoE. In the?U.S.?there are approximately 160,000 patients with EoE who are currently treated, of whom approximately 48,000 have failed multiple treatments.
"The current standard of care for people with eosinophilic esophagitis may only provide limited relief of their symptoms. Efforts to develop a treatment that targets an underlying cause of the disease has eluded the field for some time, resulting in an incredible unmet need,"?said?Naimish Patel,?M.D. Head?of?Global Development, Immunology and Inflammation at Sanofi.?"We are encouraged that Dupixent, which targets IL-4 and IL-13, was able to reduce inflammation in the esophagus and provided significant relief when swallowing for patients taking the weekly dose. We look forward to continuing to study Dupixent's potential role in addressing the underlying type 2 inflammation that can lead to eosinophilic esophagitis."
In this trial, 80 patients were enrolled into a Dupixent 300 mg weekly treatment group and 79 patients were enrolled into the placebo group. The co-primary endpoints at 24 weeks assessed patient-reported measures of difficulty swallowing (change from baseline in the Dysphagia Symptom Questionnaire, or DSQ), and esophageal inflammation (proportion of patients achieving peak esophageal intraepithelial eosinophil count of =6 eos/high power field [hpf]).
Patients treated with Dupixent 300 mg weekly experienced the following changes by week 24 compared to placebo:
SOURCE?Regeneron Pharmaceuticals, Inc.
- 64% reduction in disease symptoms from baseline compared to 41% for placebo (p=0.0008). Dupixent patients experienced a 23.78 point improvement on the 0-84 DSQ scale, compared to a 13.86 point improvement for placebo (p<0.0001); baseline DSQ scores were approximately 38 and 36 points, respectively.
- Nearly 10 times as many Dupixent patients achieved histological disease remission: 59% of patients achieved histological disease remission compared to 6% of placebo patients (p<0.0001). This was measured by the proportion of patients who achieved a peak esophageal intraepithelial eosinophil count of =6 eos/hpf; mean baseline peak levels were 89 and 84 eos/hpf, respectively.
- to treat people?aged 6 years and?older?with moderate-to-severe?atopic dermatitis (eczema) 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?years of?age.
- with other asthma?medicines?for the maintenance?treatment?of?moderate-to-severe eosinophilic or?oral?steroid?dependent?asthma?in?people aged?6?years 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.?DUPIXENT?is?not?used to?treat?sudden?breathing?problems. 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 polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.
- have eye problems
- have a parasitic (helminth) infection
- are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated 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.
- Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis.?Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: breathing problems, fever, general ill feeling, swollen lymph nodes, swelling of the face, mouth and tongue, hives, itching, fainting, dizziness, feeling lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.
- 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, shortness of breath, persistent fever, chest pain, or a feeling of pins and needles or numbness of your arms or legs.
- Atopic dermatitis:?injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, and cold sores in your mouth or on your lips.
- Asthma:?injection site reactions, pain in the throat (oropharyngeal pain), high count of a certain white blood cell (eosinophilia), and parasitic (helminth) infections.
- Chronic rhinosinusitis with nasal polyposis:?injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, high count of a certain white blood cell (eosinophilia), trouble sleeping (insomnia), toothache, gastritis, and joint pain (arthralgia).
Regeneron Contacts: Media Relations Sharon Chen Tel: +1 914-847-1546 Sharon.Chen@regeneron.com?? | Investor Relations Vesna Tosic Tel: +1 914-847-5443 Vesna.Tosic@regeneron.com? |
Sanofi Contacts: Media Relations Sally Bain Tel: +1 781-264-1091 Sally.Bain@sanofi.com | Investor Relations Sanofi Investor Relations ? Contacts Paris Eva Schaefer-Jansen Arnaud Delepine Nathalie Pham Sanofi Investor Relations ? Contact?North America Felix Lauscher Sanofi IR main line: Tel: +33 (0)1 53 77 45 45 investor.relations@sanofi.com? https://www.sanofi.com/en/investors/contact |