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Regeneron Pharmaceuticals : Dupixent Late-breaking Pivotal Data Showing Significant Improvement in Eosinophilic Esophagitis Signs and Symptoms

10/27/2020 | 08:47am

TARRYTOWN - 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 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: Rapid improvement in ability and comfort of swallowing: patients reported significant improvement on the Dysphagia Symptom Questionnaire (DSQ) as early as 4 weeks and continued to improve through 24 weeks (p

(C) 2020 Electronic News Publishing, source ENP Newswire

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