Dupixent 300 mg weekly significantly improved the ability to swallow and reduced eosinophils in the esophagus compared to placebo, reinforcing positive results from first Phase 3 trial

Eosinophilic esophagitis is a progressive disease that damages the esophagus and impairs the ability to swallow; 90% of trial participants had at least one coexisting type 2 inflammatory condition such as asthma or atopic dermatitis

Dupixent is the only biologic medicine to show positive, clinically meaningful Phase 3 results in these patients; regulatory filings planned for 2022

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi 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: 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

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