FMT Update & Future Directions

Dear Friends and Colleagues,

I am writing to share an important and transformative update about OpenBiome.

In light of the FDA’s recent decision to end enforcement discretion, we have had to make some difficult decisions—most notably, scaling back our exceptional team and ceasing the distribution of investigational Fecal Microbiota Transplants (FMT). The outcome, although unavoidable, deeply affects us all as we fully recognize the critical role this treatment has played for clinicians and the patients you care for, particularly those battling severe and fulminant Clostridioides difficile (C. diff) infections. Rest assured, however, that while it may take time, we are actively exploring new avenues to ensure patients can access this life-changing therapy.

While navigating these complexities, I want to reflect on the extraordinary journey we’ve undertaken together. Our work has highlighted the profound influence of the gut microbiome on human health and propelled microbiome science into the mainstream of medical research – resulting in two FDA-approved live biotherapeutic products for the prevention of C. diff recurrence. Together, we have pioneered therapeutic innovations that have touched the lives of more than 70,000 patients. We’ve advanced clinical research and built a foundation of knowledge across a diverse range of indications, including inflammatory bowel disease, antimicrobial resistance, autoimmune, metabolic, and neurological diseases.

This is not an ending, but rather a new chapter for OpenBiome. The research conducted within our network has demonstrated the life-changing potential of microbiome-based therapies. We have witnessed their transformative power firsthand and remain steadfast in our commitment to ensuring that this field’s promise is fully realized for the benefit of patients everywhere.

This transition will undoubtedly demand resilience and adaptability. Yet, I am confident that by embracing this new chapter with the same spirit of innovation, collaboration, and unwavering commitment that has defined our journey thus far, we will continue to shape the future of microbiome science and make lasting contributions to improving human health.

Thank you for being an essential part of this journey. Your dedication to advancing care and supporting patients has been—and will remain—at the heart of everything we do. Together, we will continue to push boundaries and create a healthier future. Please stay tuned for more important updates about OpenBiome’s future and the exciting new directions we are exploring.

With sincere gratitude,

Julie Barrett O’Brien