[临床][积极进展]Zydus在ACG 2026公布saroglitazar治疗PBC的III期EPICS-III事后分析:美国亚组生化应答差异大于非美国亚组
Zydus Therapeutics Presents New Post Hoc Analysis of Phase 3 EPICS-III Trial at ACG 2026 Showing Greater Biochemical Response With Investigational Saroglitazar Compared to Placebo Across Geographic Subgroups in PBC
Zydus Therapeutics在ACG 2026年会以late-breaking口头报告形式公布saroglitazar治疗原发性胆汁性胆管炎(PBC)III期EPICS-III试验的地理亚组事后探索性分析。该试验为随机、双盲、安慰剂对照的无缝II(b)/III期研究,入组对熊去氧胆酸(UDCA)应答不足或不耐受的成人PBC患者,随机148例按2:1接受saroglitazar magnesium 1 mg或安慰剂。事后分析显示,复合生化应答率在saroglitazar组高于安慰剂组:美国亚组为60.7% vs 0%(28例 vs 14例),非美国亚组(阿根廷、冰岛、土耳其)为55.1% vs 13.5%(69例 vs 37例);美国亚组未分层治疗差异(∆60.7%)大于非美国亚组(∆41.6%)。 公司:Zydus Therapeutics 相关资产:saroglitazar 适应症:原发性胆汁性胆管炎(PBC) 阶段:III期(EPICS-III Phase 2(b)/3)事后分析,FDA审评中 融资性质:不适用 来源:BioSpace · 新闻稿(https://www.biospace.com/press-releases/zydus-therapeutics-presents-new-post-hoc-analysis-of-phase-3-epics-iii-trial-at-acg-2026-showing-greater-biochemical-response-with-investigational-saroglitazar-compared-to-placebo-across-geographic-subgroups-in-pbc)
来源:BioSpace · 新闻稿 · biospace.com
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