新型抗生素在艰难梭菌II期研究中显示出强大的治疗潜力

2020-11-21 MedSci原创 MedSci原创

Ibezapolstat将10例艰难梭菌感染患者全部治愈,并且30天内未复发。

Acurx Pharmaceuticals公司近日宣布新型抗生素II期临床试验的阳性结果,该候选抗生素是一种称为ibezapolstat的DNA聚合酶IIIC抑制剂,用于治疗CDI(艰难梭菌感染)。DNA pol IIIC仅在某些革兰氏阳性细菌中发现,在细菌复制和致病中起着关键作用。

II期试验的A部分招募了20例由艰难梭菌引起的腹泻患者,10位患者口服450毫克ibezapolstat,完成治疗10天后进行评估。

结果显示参加试验的10位患者全部达到了研究的主要和次要疗效终点:治疗结束后,10例患者均被治愈且28天内未复发。并且ibezapolstat具有良好的耐受性,未报告严重不良事件(SAE)。

该研究首席研究员Garey博士强调一个理想的口服CDI抗生素必须要具备几项关键特性:抗艰难梭菌的高效选择性、安全性和结肠不吸收(导致结肠的高浓度)。Garey博士说:“治疗CDI的总体目标是杀死艰难梭菌并恢复健康的微生物组环境。Ibezapolstat可抑制变形菌的再生,从而有减少复发的可能性。这与II期A段数据一致,该数据显示初始治愈后30天没有复发。”

2018年,美国食品和药物管理局(FDA)为ibezapolstat授予合格传染病产品(QIDP)称号,作为CDI患者的口服治疗药物。QIDP的指定意味着ibezapolstat会获得“优先审查”并有资格授权“快速通道”。

原始出处:

https://www.europeanpharmaceuticalreview.com/news/134034/novel-antibiotic-shows-promise-in-phase-ii-c-difficile-study/

https://www.acurxpharma.com/news-media/videos/video/2906/video-presentation-of-clinical-data-by-dr-kevin-garey

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    2021-01-09 zb1235672

    学习了

    0

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    2020-11-25 12124100m65暂无昵称

    好棒的研究受益匪浅

    0

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    2020-11-22 lovetcm

    #Ibezapolstat#这么厉害,能对抗#艰难梭菌#

    1

    展开1条回复
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    2020-11-21 ms8000000222257526

    太有用了

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