Phase III trial of Dupixent meets endpoints in eosinophilic esophagitis.- Sanofi/Regeneron Pharma

Sanofi and Regeneron Pharmaceuticals announced positive results from Part A of the pivotal Phase III trial evaluating Dupixent (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). The trial met both of its co-primary endpoints, as well as all key secondary endpoints. Dupixent is the first and only biologic to show positive and clinically-meaningful results in this population as part of a Phase III trial. An ongoing Part B portion of the Phase III trial evaluates an additional Dupixent dosing regimen. Part A of the trial enrolled 81 patients (42 with Dupixent, 39 with placebo) aged 12 years and older with EoE, as determined by histological and patient-reported measures. The co-primary endpoints assessed the change from baseline in the Dysphagia Symptom Questionnaire (DSQ), a patient-reported measure of difficulty swallowing, and the proportion of patients achieving peak esophageal intraepithelial eosinophil count of <=6 eos hpf a measure of an esophageal inflammation at 24 weeks. patients treated with dupixent 300 mg weekly experienced the following changes by week 24 from baseline: a 69 reduction in disease symptoms compared to 32 for placebo p="0.0002)." disease symptoms were measured by the dsq scale where patients experienced a 21.92 point improvement with dupixent compared to a 9.60 point improvement for placebo on a 0-84 scale p="0.0004)," the co-primary endpoint baseline dsq scores were approximately 34 points. a 60 reduction in their esophageal eosinophilic count to a normal range compared to 5 for placebo p><0.0001), the co-primary endpoint. this was measured by the proportion of patients who achieved a peak esophageal intraepithelial eosinophil count of><=6 eos hpf a normal range mean baseline peak levels were 89 eos hpf. a 39 reduction in abnormal endoscopic findings compared to 0.6 worsening for placebo. this was measured by the eoe endoscopic reference score eoe-erefs where patients experienced a 3.2 point reduction with dupixent compared to a 0.3 point reduction for placebo p><0.0001). the trial demonstrated similar safety results to the known 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 and n="12" for placebo and upper respiratory-tract infections n="11" for dupixent and n="6" for placebo. there was one treatment discontinuation in the dupixent group due to arthralgia. detailed results from this trial will be presented at an upcoming medical meeting.>