Fecal transplant pills: Large-scale production begins following successful dosing study

Nonprofit stool bank launched by MIT researchers will provide the first fecal transplant pill for clinical use

MEDFORD, Mass — A new pill created by a team of MIT-trained researchers provides fecal transplant therapy without requiring the traditional, more invasive stool delivery methods.

The FMT Capsule G3 pills will serve as a treatment option for recurrent Clostridium difficile infections (rCDI) that don’t respond to standard antibiotic treatment. The pill will also serve as a new tool for researching future applications of microbiome-based therapies.

Fecal microbiota transplantation, or FMT, is procedure in which a stool preparation from a healthy human donor is infused into the intestine of a patient. It is typically delivered via colonoscopy, enema, or a plastic tube inserted through the nose into the stomach or intestines.

Delivering fecal microbiota transplantation by pill reduces both the procedural costs and risks associated with the more invasive delivery methods. It was the strongly preferred by patients in a survey published in Clinical Infectious Diseases.

The pill was created by OpenBiome, a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation therapies and catalyzing research into the human microbiome. Founded in 2012 by a team of microbiologists, clinicians, and public health advocates from Harvard and MIT, OpenBiome has since provided over 7000 treatments to more than 450 clinical partners across six countries, and has supported 10 clinical and translational research studies.

OpenBiome’s FMT Capsule G3 uses a patent-pending Microbial Emulsion Matrix (MEM) technology, which preserves the viability of complex bacterial communities while ensuring capsules’ long-term physical stability. This feature allows for widespread provision of a fecal transplant pill—encapsulation methodologies used in the field to date have yielded capsules that degraded within minutes. The MEM technology was presented at the American College of Gastroenterology’s annual scientific meeting on October 18th.

Fecal microbiota transplantation has been shown across multiple studies to be 89 percent effective in treating Clostridium difficile infection, while standard antibiotic therapies yield cure rates of less than 40 percent. C. difficile is the most common hospital-acquired infection in the U.S., and one in five patients with C. difficile will have to endure the infection more than once.

Results from a pilot, multi-center randomized dose-finding study with 17 patients led by Dr. Monika Fischer, MD, MSCR, Clinical Assistant Professor of Medicine at Indiana University, and Dr. Jessica Allegretti, MD, MPH, associate gastroenterologist at Brigham and Women’s Hospital and instructor of medicine at Harvard Medical School, found an initial efficacy rate of 70 percent in both low and high dose groups receiving OpenBiome’s FMT capsules. Treatment with a high dose after an initial nonresponse yielded an aggregate clinical cure rate of 94 percent. There were no adverse events reported.

The results, presented on Monday morning at an award-winning late-breaking oral presentation at United European Gastroenterology Week in Barcelona, Spain, are comparable to previously published investigations of the efficacy of encapsulated FMT. The abstract may be viewed using the conference’s online program tool.

“This is a compelling step towards providing evidence-based FMT capsule treatments for patients,” said Dr. Zain Kassam, MD, MPH, Chief Medical Officer of OpenBiome. “Although colonoscopic delivery remains the gold standard for FMT in terms of efficacy, these results suggest that FMT capsules may emerge as an effective and less invasive therapy option. We hope to help usher in a universe in which patients suffering from this crippling diarrheal infection have safe access to FMT without having to undergo a procedure.”

Similar to other microbiota preparations already provided by OpenBiome, FMT Capsule G3 may be used to treat patients with rCDI under the FDA’s enforcement discretion guidelines, or to treat other conditions under an Investigational New Drug application. Encapsulated FMT is a particularly useful tool for clinical research because it allows investigators to evaluate maintenance FMT therapy without requiring participants to undergo repeated invasive procedures.

“OpenBiome’s FMT Capsule G3 is a major step forward for FMT patients, physicians, and clinical researchers because it reduces the procedure-related risks and discomforts of FMT,” said Dr. Mark Smith, PhD, Research Director at OpenBiome. “We have already seen the remarkable impact of standardizing FMT for the treatment of rCDI through traditional routes of administration, and we are thrilled to add capsules as a new option to further expand patients’ safe access to care.”

To learn more about OpenBiome’s FMT Capsule G3, please visit www.openbiome.org/fmtcapsules.

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