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【Portfolio】安济药业顺利完成ANJ908全球2期临床试验入组

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​​文章来源:安济药业

中国上海和美国麻省剑桥,2022年05月20日–安济药业欣然宣布,其全球首创机制创新药pradigastat(ANJ908)的全球2期概念验证临床试验已顺利完成入组。ANJ908是选择性二酰基甘油酰基转移酶1(DGAT1)抑制剂,拟用于治疗功能性便秘。

本临床试验是一项随机、双盲、安慰剂对照的概念验证研究,旨在评估pradigastat对功能性便秘患者的有效性、安全性和耐受性。该研究招募了超过180名便秘患者作为受试者。受试者每日服用一片20mg或40mg的pradigastat或安慰剂。研究主要终点为第4周自发排便(SBM)次数与基线相比的变化。关键次要终点是第4周完全自发排便(CSBM)次数与基线相比的变化。详情请查阅:www.clinicaltrials.gov(NCT04620161)

本研究由上海交通大学医学院附属瑞金医院牵头,在20个中国临床中心和5个美国临床中心完成。瑞金医院消化科主任及内镜中心主任邹多武教授表示:“我很高兴作为主要研究者领导开发ANJ908这一全球首创机制的便秘治疗药物。这是全球首次将干预DGAT1靶点作为便秘治疗策略的概念验证临床试验,将为后续研究设计打下结实基础。由瑞金医院牵头的中美25家中心共同努力,克服疫情挑战,历经16个月成功完成入组,可喜可贺。”

安济药业的医学总监杨明表示:“感恩中国和美国各研究中心所有研究者和工作人员的不懈努力,感谢在疫情期间坚守一线的CRA和CRC小伙伴们的辛勤工作。我们将继续积极推进整个项目的研发,希望早日为便秘患者带来安全有效的治疗药物。”

安济药业计划在2022年下半年发布本研究的数据和结果,并在2023年启动全球3期临床试验。

关于Pradigastat

Pradigastat是二酰基甘油酰基转移酶1(DGAT1)的抑制剂,在食物甘油三酯的重组中起关键作用,并充当膳食脂肪摄入的传感器。Pradigastat通过抑制DGAT1,进而提高肠腔中的脂肪酸水平来改变肠道环境,从而促进结肠蠕动和水分分泌,以有效治疗便秘。Pradigastat有望显著改善功能性便秘和便秘型肠易激综合征(IBS-C) 的治疗,而目前这两种流行疾病缺乏行之有效的治疗方法。

 

关于安济药业

安济药业是一家临床阶段生物制药公司,致力于为患者提供创新疗法以显著提升生命质量。安济的商业模式以产品管线为中心,采用“hub-and-spoke”模式,充分发挥临床开发的核心能力,快速灵活地创造临床价值。安济正在进行后期临床开发的创新药物包括:盐酸二甲双胍迟释片(ANJ900– 全球临床3期),用以有效管理合并中重度慢性肾病的2型糖尿病患者的血糖水平;以及pradigastat(ANJ908 – 全球临床2期),用于治疗慢性便秘。更多信息,请访问www.anjipharma.com

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