Pribyl Alena L, Hugenholtz Philip, Cooper Matthew A
Microba Life Sciences, Brisbane, Queensland, Australia.
The University of Queensland, School of Chemistry and Molecular Biosciences, Australian Centre for Ecogenomics, Brisbane, Queensland, Australia.
Nat Microbiol. 2025 Feb;10(2):301-312. doi: 10.1038/s41564-024-01896-3. Epub 2025 Jan 8.
Microbiome science has evolved rapidly in the past decade, with high-profile publications suggesting that the gut microbiome is a causal determinant of human health. This has led to the emergence of microbiome-focused biotechnology companies and pharmaceutical company investment in the research and development of gut-derived therapeutics. Despite the early promise of this field, the first generation of microbiome-derived therapeutics (faecal microbiota products) have only recently been approved for clinical use. Next-generation therapies based on readily culturable and as-yet-unculturable colonic bacterial species (with the latter estimated to comprise 63% of all detected species) have not yet progressed to pivotal phase 3 trials. This reflects the many challenges involved in developing a new class of drugs in an evolving field. Here we discuss the evolution of the live biotherapeutics field over the past decade, from the development of first-generation products to the emergence of rationally designed second- and third-generation live biotherapeutics. Finally, we present our outlook for the future of this field.
在过去十年中，微生物组科学发展迅速，一些备受瞩目的出版物表明，肠道微生物组是人类健康的一个因果决定因素。这导致了专注于微生物组的生物技术公司的出现，以及制药公司对肠道衍生疗法研发的投资。尽管该领域早期前景乐观，但第一代微生物组衍生疗法（粪便微生物群产品）直到最近才被批准用于临床。基于易于培养和尚未培养的结肠细菌物种（据估计，后者占所有检测到物种的63%）的下一代疗法尚未进入关键的3期试验。这反映了在一个不断发展的领域开发一类新型药物所涉及的诸多挑战。在这里，我们讨论了过去十年中活体生物治疗领域的发展，从第一代产品的开发到合理设计的第二代和第三代活体生物治疗的出现。最后，我们阐述了对该领域未来的展望。
