[临床][常规进展]Eupraxia Pharmaceuticals的RESOLVE试验达到120例入组目标，评估EP-104GI治疗嗜酸性食管炎
Eupraxia Pharmaceuticals Reaches its Enrollment Target for the RESOLVE Trial Investigating EP-104GI for the Treatment of Eosinophilic Esophagitis
Eupraxia Pharmaceuticals宣布其评估EP-104GI治疗嗜酸性食管炎（EoE）的RESOLVE试验已达到120例患者入组目标。该试验的Phase 2b安慰剂对照盲法部分于2026年10月12日完成第120例患者入组和治疗，患者按1:1:1随机接受120mg（20x6mg）、160mg（20x8mg）EP-104GI或载体对照。公司统计团队对非盲数据进行定期审查后确认，原设计的样本量无需调整，无需增加入组。在RESOLVE试验的开放标签Phase 1b/2a和安慰剂对照Phase 2b两部分中，EP-104GI或载体已累计给药超过3,000次注射，未出现治疗相关严重不良事件（SAEs）。Phase 2b部分的期中分析预计于2026年12月进行，将报告前60例达到6个月患者的症状、组织学发现和安全性数据，同时提供3个月、9个月和12个月时间点的数据。
新闻事实
- 研发公司
- Eupraxia Pharmaceuticals Inc.
- 相关资产
EP-104GI · 本次主资产
所属公司：Eupraxia Pharmaceuticals Inc.
Eosinophilic Esophagitis (EoE)／adults with a history of confirmed active EoE — Phase 1b/2a
Eosinophilic Esophagitis (EoE)／adults — Phase 2b
- 公司管线
Diffusphere™ technology platform
所属公司：Eupraxia Pharmaceuticals Inc.
适应症／人群未披露 — 阶段未披露
- 本次进展
EP-104GI · Eosinophilic Esophagitis (EoE) · RESOLVE
Phase 2b placebo-controlled blinded portion reached target enrollment of 120 patients; 120th patient enrolled and treated on October 12, 2026
Patients randomized 1:1:1 to EP-104GI 120mg (20x6mg), 160mg (20x8mg) or vehicle control
Sequestered data management group periodic reviews confirmed sample size does not need adjustment
Interim analysis of Phase 2b portion on track for December 2026, reporting symptoms, histologic findings and safety in first 60 patients reaching 6 months, with 3-, 9- and 12-month data also available
Across Phase 1b/2a and Phase 2b, over 3,000 injections of EP-104GI or vehicle administered with no treatment-related Serious Adverse Events (SAEs); EP-104GI generally well-tolerated
- 本次进展
EP-104GI · Eosinophilic Esophagitis (EoE) · RESOLVE Phase 1b/2a
Background study (not the current new event): multicenter, open-label, dose-escalation study in adults with confirmed active EoE; single dose via 4 to 20 esophageal wall injections; patients followed up to 24 weeks in Cohorts 1-4 or 52 weeks in Cohorts 5-9
Additional data from the open-label Phase 1b/2a portion planned to be disclosed in the coming months
来源：BioSpace · 新闻稿 · biospace.com
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