OpenBiome Ships 70,000th Investigational FMT to Treat C. difficile

WOBURN, MA (February 13, 2024) – This week, OpenBiome passed the milestone of shipping its 70,000th investigational Fecal Microbiota Transplantation (FMT) preparation for the treatment of recurrent Cloistridiodes difficile infection, a life-threatening disease, and to advance clinical research on the microbiome.

OpenBiome Staff

An estimated 500,000 patients are diagnosed with C. difficile infection in the US annually.  Infection is often preceded by disruptions to the gut microbiota after antibiotic therapy for other infections. Treatment options are limited for patients who experience recurrent disease and C. difficile leads to nearly 30,000 deaths per year in the US. For those living with recurrent infections and who fail standard therapy, it can have a devastating impact on their lives.

Continuing its commitment to leave no patient behind, Julie Barrett O’Brien, CEO, OpenBiome, a health research nonprofit, said: “This is a great day for us, reinforcing the critical need to make sure that all those suffering from C. difficile continue to have safe access to affordable therapeutics. Each hour, every day, our work proves that human microbes can treat incurable illnesses, such as C. diff. And we would not be where we are today without our incredible community of clinical partners, scientists, patients, advocates, and philanthropists who helped bridge the treatment gap.”

The 70,000 treatment was shipped to Lahey Hospital & Medical Center, Burlington, MA. Lahey Hospital & Medical Center’s Division of Gastroenterology has been at the forefront of using FMT for C. difficile infection since the early days of this investigational treatment becoming available.

“The Gastroenterology Department at Lahey Hospital & Medical Center (LHMC) has seen considerable success in the use of fecal microbiota transplantation in the treatment of patients with recurring Clostridium difficile infections (C. diff),” said Anna Leszczynski, MD, Director of Fecal Microbial Transplant at Lahey Hospital & Medical Center, part of Beth Israel Lahey Health. “We are proud to offer this important treatment at LHMC as an effective alternative to C. diff patients with severe infection found nonresponsive to more traditional antibiotic therapy.”

Lahey Hospital & Medical Center is part of OpenBiome’s clinical network, which includes 735-plus clinical partners who provide safe access to investigational treatments for C. difficile.

If not for this network, many patients may fall through the cracks. These include patients who are ineligible for, have failed or who do not have access to other gut microbiota directed therapies. These include patients suffering from fulminant C. difficile infection, the most severe form of disease. Along with our manufacturing partners at the University of Minnesota, OpenBiome will continue to distribute investigational FMT treatments for patients who have exhausted existing therapies while it works closely with the US Food & Drug Administration (FDA) to align with the finalized regulatory guidance on FMT access for C. difficile infection.

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OpenBiome
OpenBiome is a pioneering nonprofit microbiome health organization.  Its mission is to accelerate microbiome science to improve health for all. OpenBiome partners with leading researchers, clinicians, and innovators to advance and ensure access to novel and affordable microbiome therapeutics.