Paquet Jeanne-Céleste, Claus Sandrine P, Cordaillat-Simmons Magali, Mazier Wilfrid, Rawadi Georges, Rinaldi Laure, Elustondo Frédéric, Rouanet Alice
Ysopia Bioscience, Bordeaux, France.
Pharmabiotic Research Institute - PRI, Narbonne, France.
Front Med (Lausanne). 2021 Aug 11;8:716266. doi: 10.3389/fmed.2021.716266. eCollection 2021.
During the last decade, a plethora of novel therapies containing live microorganisms as active substance(s) has emerged with the aim to treat, prevent, or cure diseases in human beings. Both the Food and Drug Administration (FDA) and the European Directorate for the Quality of Medicines and Health Care (EDQM) codified these biotherapies as Live Biotherapeutic Products (LBPs). While these innovative products offer healthcare opportunities, they also represent a challenge for developers who need to set the most suitable designs for non-clinical and clinical studies in order to demonstrate a positive benefit/risk ratio through relevant quality, safety, and efficacy data that are expected by the drug competent authorities. This article describes how YSOPIA Bioscience, supported by the Pharmabiotic Research Institute (PRI), addressed the regulatory challenges during the early development phase of their single-strain LBP, Xla1, in order to obtain the necessary authorizations to bring this drug to the clinical stage.
在过去十年中，出现了大量含有活微生物作为活性物质的新型疗法，旨在治疗、预防或治愈人类疾病。美国食品药品监督管理局（FDA）和欧洲药品质量管理局（EDQM）都将这些生物疗法编纂为活体生物治疗产品（LBPs）。虽然这些创新产品提供了医疗保健机会，但它们对开发者来说也是一个挑战，开发者需要为非临床和临床研究设定最合适的设计，以便通过药品主管当局期望的相关质量、安全性和有效性数据来证明积极的效益/风险比。本文描述了YSOPIA生物科学公司在药物共生研究所（PRI）的支持下，如何在其单菌株LBP Xla1的早期开发阶段应对监管挑战，以便获得将该药物推进到临床阶段所需的授权。
