Microbiotica has completed patient enrollment in its Phase 1b COMPOSER-1 trial of MB310, a live biotherapeutic product (LBP) for the treatment of ulcerative colitis (UC). The 29-patient study, conducted across five European countries, is evaluating the safety, tolerability, and preliminary efficacy of MB310 in adults with mild-to-moderate UC. Initial results are anticipated by the end of 2025.
This trial represents a key step in Microbiotica’s strategy to translate promising fecal microbiota transplantation (FMT) data into a defined, scalable LBP. The company previously analyzed clinical and microbiome data from a University of Adelaide FMT study, identifying specific bacterial strains associated with favorable clinical responses in UC patients. These strains form the basis of MB310, administered as an oral capsule. Preclinical data suggest that MB310 acts through multiple mechanisms relevant to UC pathology, including gut barrier repair, cytokine modulation, and the induction of regulatory T cells.
The move toward defined LBPs reflects a broader industry effort to standardize and control the therapeutic potential of microbiome modulation. While FMT has shown efficacy in UC, its inherent variability and logistical complexities limit broader clinical adoption. Microbiotica’s approach seeks to overcome these limitations by developing a precisely formulated, orally delivered product amenable to conventional manufacturing and distribution.
The COMPOSER-1 trial’s design, focusing on safety, tolerability, and engraftment alongside exploratory efficacy endpoints, highlights the nascent stage of microbiome-based therapeutics. For research sites, the study presents both opportunities and challenges related to patient recruitment and standardized administration of LBPs. For regulators, the trial will contribute valuable data on the safety and mechanistic activity of defined bacterial consortia, potentially informing future guidance on LBP development.
Looking ahead, the success of COMPOSER-1 hinges not only on demonstrable clinical benefit but also on evidence of consistent engraftment of the MB310 bacterial strains. This will be critical for establishing a predictable dose-response relationship and supporting claims of therapeutic efficacy. Positive data could pave the way for larger-scale trials and position Microbiotica to compete in the emerging market for microbiome-based UC treatments. However, longer-term challenges remain, including demonstrating durability of response and navigating potential manufacturing and regulatory hurdles associated with live biological products. Ultimately, the trial’s outcome will contribute to the ongoing debate about the role of defined LBPs versus whole FMT in managing chronic inflammatory bowel disease (IBD) and other chronic inflammatory conditions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
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