Phase III trial of SHP 621 meets co-primary endpoints in eosinophilic esophagitis.- Takeda

Takeda Pharmaceuticals announced that SHP 621 (budesonide oral suspension) or BOS, its investigational therapy for the treatment of eosinophilic esophagitis (EoE), achieved co-primary and key secondary efficacy outcomes with statistical significance compared to placebo in the first of two pivotal Phase III studies. Positive results on clinical endpoints were presented from a randomized, double-blind, placebo-controlled trial that investigated the safety and efficacy of BOS over 12 weeks of treatment among adolescent and adult patients aged 11 to 55.

This is the first pivotal Phase III study investigating an EoE treatment ever to be reported in the United States and is the largest EoE clinical trial program conducted to date, globally. Study results found significantly more histologic responders and dysphagia symptom responders in the BOS-treated group versus the placebo-treated group (53.1% vs 1.0%, P< .001; 52.6% vs 39.1%, P=.024, respectively). Improvements in mean DSQ score from baseline to week 12 were also significantly greater in the BOS group (n=197) than the placebo group (n=89) (-13.0 vs -9.1; P=.015). Similarly, improvements in mean EREFS scores were significantly greater with BOS (n=202) than placebo (n=93) (-4.0 vs -2.2; P< .001). In total, 61.0 percent (194/318) of patients reported a TEAE [BOS, 61.0% (130/213); placebo, 61.0% (64/105)], with 2.5 percent of patients experiencing a TEAE leading to dose discontinuation (BOS, 1.4%; placebo, 4.8%).

TEAEs that affected 2 percent or more of the patients in either the placebo or BOS arm of the study included nasopharyngitis, sinusitis, esophageal candidiasis, oral candidiasis and upper respiratory tract infection. TEAEs of candidiasis such as oral or esophageal candidiasis were seen in fewer than 5 percent of patients overall and in either treatment group. Rates of individual TEAEs such as oral candidiasis cannot yet be disclosed by treatment group until the maintenance study completes. There were no life-threatening TEAEs or deaths reported.Results on histologic, symptomatic and endoscopic endpoints were presented during a Presidential Plenary Session of the 2019 American College of Gastroenterology Annual Scientific Meeting.