The extensive investigation of the human microbiome and the accumulating evidence regarding its critical relationship to human health and disease has advanced recognition of its potential as the next frontier of drug development. The rapid development of technologies, directed at understanding the compositional and functional dynamics of the human microbiome, and the ability to mine for novel therapeutic targets and biomarkers is leading innovative efforts to develop microbe-derived drugs that can prevent and treat autoimmune, metabolic, and infectious diseases. Increasingly academics, biotechs, investors, and large pharmaceutical companies are partnering to collectively advance various therapeutic modalities ranging from live bacteria to small molecules. We review the leading platforms in current development focusing on live microbial consortia, engineered microbes, and microbial-derived metabolites. We will also touch on how the field is addressing and challenging the traditional definitions of pharmacokinetics and pharmacodynamics, dosing, toxicity, and safety in order to advance the development of these novel and cutting-edge therapeutics into the clinic.

中文翻译：

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将虫子设计为药物：利用肠道微生物组

对人类微生物组的广泛调查以及关于其与人类健康和疾病的关键关系的越来越多的证据，已经提高了人们对其作为药物开发下一个前沿领域的潜力的认识。技术的快速发展，旨在了解人类微生物组的组成和功能动态，以及挖掘新治疗靶点和生物标志物的能力，正在引领创新努力开发能够预防和治疗自身免疫、代谢和传染性疾病。越来越多的学者、生物技术公司、投资者和大型制药公司正在合作共同推进从活细菌到小分子的各种治疗方式。我们回顾了当前开发中的领先平台，重点是活微生物联合体，工程微生物和微生物衍生的代谢物。我们还将探讨该领域如何解决和挑战药代动力学和药效学、剂量、毒性和安全性的传统定义，以推动这些新型和尖端疗法进入临床。