OpenBiome develops FMT pill for recurrent C. difficile infection

Nonprofit stool bank OpenBiome announced that large-scale production of the first fecal microbiota transplant pill for clinical use will begin following a successful dosing study, which was recently presented at UEG Week.

The FMT Capsule G3 pill will be a lower-cost alternative to more invasive FMT delivery methods for patients with recurrent Clostridium difficile infection (rCDI) who do not respond to standard antibiotic therapy, according to a press release. Like other FMT preparations provided by OpenBiome, this pill can be used to treat patients with rCDI under the FDA’s enforcement discretion guidelines. The pill will also be useful in microbiome-based therapeutic research applications.

Mark Smith

Zain Kassam

“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,” Mark Smith, PhD, research director at OpenBiome, said in the press release. “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.”

The pills are created using a novel, patient-pending approach called Microbial Emulsion Matrix, or MEM, technology, which was presented by OpenBiome’s Zain Kassam, MD, MPH, at ACG 2015. MEM technology “preserves the viability of complex bacterial communities while ensuring capsules’ long-term physical stability,” according to the press release. “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.”

Large-scale production of the FMT Capsule G3 has been initiated following the UEG Week presentation of results from a dose-finding pilot study, delivered by Jessica Allegretti, MD, MPH, from Brigham and Women’s Hospital and Harvard Medical School, which showed a 70% efficacy rate of both high- and low-dose FMT capsules, and a 94% aggregate clinical cure rate following treatment with high-dose capsules in nonresponders.

“This is a compelling step towards providing evidence-based FMT capsule treatments for patients,” Kassam said in the press release. “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.”

References:

Allegretti J, et al. Abstract OP054-LB7. Presented at: UEG Week; Oct. 24-27, 2015; Barcelona, Spain.

Kassam Z, et al. Abstract P107. Presented at: ACG 2015; Oct. 19-21, 2015; Honolulu, HI.

Disclosures: Allegretti, Kassam and Smith report they are affiliated with OpenBiome.