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知临集团从加拿大公共卫生局获得启动ALS-4——用于治疗金黄色葡萄球菌(包括耐甲氧西林金黄色葡萄球菌(MRSA))感染的小分子药物——的临床1期试验许可

2021-01-21 国际文传 国际文传

知临集团是一家专注于针对传染病在内的新型技术的生物制药公司,宣布已通过其全资子公司Aptorum International Limited获得加拿大公共卫生局颁发的临床申请(CTA)许可

知临集团(纳斯达克股票代码:APM,巴黎泛欧证券交易所代码:APM)(“知临集团”或“知临”)是一家专注于针对传染病在内的新型技术的生物制药公司,宣布已通过其全资子公司Aptorum International Limited获得加拿大公共卫生局(Health Canada)颁发的临床试验申请(CTA)许可,以启动用于治疗由金黄色葡萄球菌(包括MRSA)所引起感染的口服小分子药物ALS-4的临床一期研究。

知临集团首席医学总监兼执行董事郑子俊博士评论说:“获得ALS-4药物CTA申请批准是该公司的重要里程碑,也是公司2021年许多战略目标之一。这一里程碑支持知临集团向临床阶段公司的过渡,并反映了我们科学严谨和产品创新的能力。我们致力于以金黄色葡萄球菌为起点,为日益增长的未被满足的传染病医疗需求提供新颖的治疗方法。”

该临床1期试验计划在加拿大进行,其目标是分别招募48位和24位健康志愿者参与单次递增剂量(SAD)和多次递增剂量(MAD)队列。该试验的主要目标是评估口服ALS-4 SAD和MAD对健康受试者的安全性和耐受性。次要目标是评估给予健康受试者口服ALS-4 SAD和MAD的药代动力学特征。

关于ALS-4

作为知临集团Acticule传染病平台的一部分,ALS-4是一种首创口服小分子药物,基于针对金黄色葡萄球菌(包括MRSA)抗毒力方法而开发。ALS-4可能会通过降低选择压力来降低抗菌素耐药性,并使细菌对宿主的免疫清除高度敏感。ALS-4的目标是与其他现有抗生素(例如万古霉素)单独或联合使用,以实现潜在的用药。

关于知临集团

知临集团(纳斯达克股票代码:APM;巴黎泛欧证券交易所:APM)是一家致力于发现、开发和商业化医疗技术,以治疗未解决的医疗需求,特别是传染病和癌症(包括孤儿肿瘤适应症)的制药公司。知临还利用多个药物发现平台以丰富其研发管线,这些平台通过诸如对现有已获批准药物分子的系统筛选和基于微生物组的代谢性疾病研究平台等来发现新的治疗项目。知临还开展了针对微生物组研究和天然补充产品商业化的项目,这些产品专门针对更年期和承受相关症状的女性。

本新闻稿并不构成知临集团的任何销售要约或者购买公司证券的实质约定。

本新闻稿包含有关知临集团及其未来预期、计划和前景的陈述,这些陈述构成1995年《私人证券诉讼改革法案》界定的“前瞻性陈述”。为此目的,此处包含的任何非陈述历史事实的陈述均可被视为前瞻性陈述。在某些情况下,您可以通过诸如“可以”、“应该”、“预期”、“计划”、“预计”、“可能”、“打算”、“目标”、“项目”、“考虑”、“相信”、“估计”、“预测”、“潜在”或“继续”,或者这些术语及其他类似表达的否定形式来识别前瞻性陈述。知临集团的这些前瞻性陈述,其中包括有关申请提交和试验的预计时间表的陈述,主要基于其目前的预期及其对认为可能影响其业务、财务状况和经营业绩的未来事件和趋势的预测。这些前瞻性陈述仅反映截至本新闻稿发布之日的信息,并受若干风险、不确定性和假设的影响,包括但不限于与其宣布的管理和组织变更相关的风险、关键人员的持续服务和可用性、其通过为其他消费者细分市场提供额外产品而扩充产品线的能力、开发结果、公司预期的成长策略、业务中的预期趋势和挑战、其对供应链的期望及供应链的稳定性,以及知临集团的20-F表格、未来知临集团可能向SEC提交的其他文件,以及于2020年7月16日获得法国第20-352号法国金融市场专员的招股说明书中更加充分描述的风险。

因此,这些前瞻性陈述中包含的预测可能会发生改变,实际结果可能与此处所述存在重大差异。知临集团不承担因新信息、未来事件或其他原因而更新本新闻稿中包含的任何前瞻性陈述的义务。

本公告不是2017年6月14日第(EU)2017/1129号条例(由2019年3月14日第(EU)2019/980号和2019年3月14日第2019/979号条例修订)定义的招股说明书。

This press release is provided “as is” without any representation or warranty of any kind.

原文阅读:http://www.businesswirechina.com/zh/news/45559.html

 

 

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    2021-04-24 宋威
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