Abstract
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.
Highlights
Effects of the microbiome on human health were described for the first time at the beginning of the 1900’s by Elie Metchnikoff [1]
While plate count and cell count methods are generally exploited for purity and potency determination, several challenges reside in the robust execution and establishment of these methods including the execution of such methods under Good Manufacturing Practices (GMP) conditions and in routine production
In August 2020, Investigational New Drug (IND) authorization was granted to Xla1 allowing Phase 1 clinical trial to begin
Summary
Effects of the microbiome on human health were described for the first time at the beginning of the 1900’s by Elie Metchnikoff [1]. Improvement of the efficiency of sequencing methods has revived interest in the microbiome field and has enabled microbiologists to perform genomics analysis and break down complex ecosystems such as human fecal material [2, 3]. The treatment of disease by way of microbiome intervention is in the realm of possibility, and several microbiome-based therapies are currently in development for this purpose, including Live Biotherapeutic Products (LBPs). Defined by the Food and Drug Administration (FDA), LBPs are biological medicinal products containing live microorganism(s) as active substance(s) [6, 7] (AS). LBPs face specific challenges inherent to their biological characteristics and modes of action
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