PDF(Pubmed)
Abstract：
UNASSIGNED: Psoriasis is a chronic inflammatory skin disease. EDP1815 is an oral, gut-restricted preparation of non-live Prevotella histicola, the first of a new immunomodulatory therapeutic class targeting the small intestine to generate systemic anti-inflammatory responses.
UNASSIGNED: To evaluate safety and efficacy of EDP1815 in mild-to-moderate psoriasis in a proof-of-concept study.
UNASSIGNED: A phase 2, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study with a 16-week treatment period and up to 24 weeks of follow-up. Participants were randomized to receive 1, 4, or 10 capsules daily.
UNASSIGNED: EDP1815 was well tolerated with comparable rates of treatment-emergent adverse events to placebo, and no drug-related serious adverse events. Clinically meaningful responses to EDP1815, defined as at least 50% reduction in Psoriasis Area and Severity Index (PASI-50) at week 16, were observed in all 3 cohorts, statistically significant in the 1-capsule (29.7%; P = 0.048) and 4-capsule (31.9%; P = 0.022) groups, compared with placebo (12.1%). Among EDP1815-treated PASI-50 responders at week 16, 60% (18/30) maintained or improved off-treatment responses at week 40.
UNASSIGNED: Continued off-treatment improvement past 16 weeks shows potential for greater therapeutic benefit that was not assessed.
UNASSIGNED: EDP1815 was well-tolerated with a placebo-like safety profile, and had meaningful efficacy outcomes in psoriasis, validating this novel immunomodulatory approach.
UNASSIGNED: https://www.clinicaltrials.gov/search?term=NCT04603027, identifier NCT04603027.
UNASSIGNED: To evaluate safety and efficacy of EDP1815 in mild-to-moderate psoriasis in a proof-of-concept study.
UNASSIGNED: A phase 2, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study with a 16-week treatment period and up to 24 weeks of follow-up. Participants were randomized to receive 1, 4, or 10 capsules daily.
UNASSIGNED: EDP1815 was well tolerated with comparable rates of treatment-emergent adverse events to placebo, and no drug-related serious adverse events. Clinically meaningful responses to EDP1815, defined as at least 50% reduction in Psoriasis Area and Severity Index (PASI-50) at week 16, were observed in all 3 cohorts, statistically significant in the 1-capsule (29.7%; P = 0.048) and 4-capsule (31.9%; P = 0.022) groups, compared with placebo (12.1%). Among EDP1815-treated PASI-50 responders at week 16, 60% (18/30) maintained or improved off-treatment responses at week 40.
UNASSIGNED: Continued off-treatment improvement past 16 weeks shows potential for greater therapeutic benefit that was not assessed.
UNASSIGNED: EDP1815 was well-tolerated with a placebo-like safety profile, and had meaningful efficacy outcomes in psoriasis, validating this novel immunomodulatory approach.
UNASSIGNED: https://www.clinicaltrials.gov/search?term=NCT04603027, identifier NCT04603027.
摘要：
■银屑病是一种慢性炎症性皮肤病。EDP1815是口头的，非活普雷沃氏菌的肠道限制性制剂，针对小肠产生系统性抗炎反应的新型免疫调节治疗方法中的第一个。
■在概念验证研究中评估EDP1815在轻度至中度银屑病中的安全性和有效性。
■第二阶段，多中心，随机化，双盲,安慰剂对照,平行组研究，为期16周的治疗期和长达24周的随访。参与者随机接受每日1、4或10粒胶囊。
■EDP1815的耐受性良好，治疗引起的不良事件发生率与安慰剂相当，无药物相关严重不良事件。在所有3个队列中观察到对EDP1815的临床意义的反应，定义为在第16周时牛皮癣面积和严重程度指数（PASI-50）至少减少50％，1胶囊（29.7％；P=0.048）和4胶囊（31.9％；P=0.022）组具有统计学意义，与安慰剂相比（12.1%）。在第16周的EDP1815治疗的PASI-50应答者中,60%(18/30)在第40周维持或改善了非治疗应答。
■过去16周持续的非治疗改善显示出更大的治疗益处的潜力，但尚未评估。
■EDP1815的耐受性良好，具有类似安慰剂的安全性，并且在牛皮癣中具有有意义的疗效结果，验证这种新的免疫调节方法。
■https://www.clinicaltrials.gov/search?term=NCT04603027，标识符NCT04603027。
■在概念验证研究中评估EDP1815在轻度至中度银屑病中的安全性和有效性。
■第二阶段，多中心，随机化，双盲,安慰剂对照,平行组研究，为期16周的治疗期和长达24周的随访。参与者随机接受每日1、4或10粒胶囊。
■EDP1815的耐受性良好，治疗引起的不良事件发生率与安慰剂相当，无药物相关严重不良事件。在所有3个队列中观察到对EDP1815的临床意义的反应，定义为在第16周时牛皮癣面积和严重程度指数（PASI-50）至少减少50％，1胶囊（29.7％；P=0.048）和4胶囊（31.9％；P=0.022）组具有统计学意义，与安慰剂相比（12.1%）。在第16周的EDP1815治疗的PASI-50应答者中,60%(18/30)在第40周维持或改善了非治疗应答。
■过去16周持续的非治疗改善显示出更大的治疗益处的潜力，但尚未评估。
■EDP1815的耐受性良好，具有类似安慰剂的安全性，并且在牛皮癣中具有有意义的疗效结果，验证这种新的免疫调节方法。
■https://www.clinicaltrials.gov/search?term=NCT04603027，标识符NCT04603027。
