OpenBiome reported that it is collaborating with the University of Minnesota’s Microbiota Therapeutics Program (MTP) to ensure that patients with recurrent Clostridium difficile (C. difficile) infections have access to fecal microbiota transplantation (FMT) until an FDA-approved alternative is available.
Through this collaboration, OpenBiome, a nonprofit organization founded to catalyze research on the microbiome’s role in human health, will distribute preparations of intestinal microbiota manufactured using Good Manufacturing Practices protocols by the University of Minnesota under the guidance of gastroenterologist Alexander Khoruts, MD, who serves as the medical director of the MTP, and microbiologist Michael Sadowsky, PhD, professor in the department of microbiology and immunology.
According to the CDC, C. difficile is a bacterium that causes severe diarrhea and colitis. It’s estimated to cause almost half-a-million infections in the U.S. each year. About one in six patients who get C. difficile will get it again in the subsequent 2-8 weeks. One in eleven people diagnosed with a healthcare-associated C. difficile infection die within one month.
Since August, OpenBiome’s microbiota bank has been providing FMT preparations for non-emergency C. difficile infections to its FMT referral network, while also providing material to all partner sites for emergency treatment of fulminant cases.
“Our team cares deeply about patients and specializes in the clinical and operational aspects of running a bank of fecal microbiota-based products,” said Khoruts, describing a program that has focused on the development of microbiota-based therapeutics.
In collaboration with the non-profit Achieving Cures Together, the MTP has provided FMT treatments to physicians and researchers since 2008, and published protocols that have been used to treat nearly 100,000 patients worldwide.
“We’re excited to team up with OpenBiome and its extensive network of clinical partners to bridge the gap in patient care and collect systematic outcome data in the real world,” added Khoruts.
OpenBiome expects to begin shipping FMT preparations manufactured by the University of Minnesota to its FMT referral network in the second half of 2022 and to continue using its own inventory for emergency treatments. Microbiota preparations from the University of Minnesota will be available in capsules for oral delivery of freeze-dried microbiota or in liquid formulations for lower intestinal delivery via colonoscopy, sigmoidoscopy, or enema.
To advance the practice of FMT, physicians will collect short-term safety and patient outcomes and enter those data into the American Gastroenterological Association’s FMT National Registry. The registry, funded by the NIH, aims to systematically track the health of 4,000 FMT recipients to better understand the risks and benefits of microbiota therapeutics.
OpenBiome’s microbiota bank was founded in 2013 to provide an immediate solution to an urgent healthcare need—treating patients with recurrent C. difficile who had failed standard antibiotic regimens, explained Julie O’Brien, OpenBiome’s executive director.
O’Brien added that since its inception, the organization has provided more than 60,000 FMT preparations to a clinical network of over 1,250 healthcare centers across the country. These investigational treatments, made available to patients outside of clinical trials through an FDA policy enacted in 2013, have served as a bridge to FDA-approved alternatives to FMT, which are expected to become available to patients in 2023, she said.
“An FDA-approved microbiota-based therapy will be a huge step forward for patient care and the microbiome field,” continued O’Brien. “It’s a day that patients and OpenBiome have been anticipating for years. Until then, we could not be more pleased to collaborate with the University of Minnesota to provide C. difficile patients with much needed treatments.”