Rebiotix, Mayo Team Up To Test Orally-Administered Gut Microbe Transplant
Rebiotix Inc., the closely held Roseville microbiome company, has teamed with a Mayo Clinic expert on hospital-acquired infections to begin the clinical trial process for a new, orally-delivered microbe transplant therapy to combat recurrent Clostridium difficile (C. diff.) infection.
Rebiotix’s “Microbiota Restoration Therapy” involves harvesting healthy, living gut microbes from donors and transplanting them into patients suffering from C. diff. infection, a serious and potentially fatal disease, characterized by severe diarrhea, fever, and loss of appetite that kills an estimated 29,000 people per year. The illness is usually acquired in hospitals after antibiotics treatments, which can kill off beneficial gut bacteria.
The new product, dubbed RBX7455, is in addition to Rebiotix’s main pharma candidate, RBX2660, which is a “fecal transplant” version of its therapy platform delivered via enema. That drug recently completed a Phase 2b randomized, double-blind, placebo-controlled trial as a possible prevention of recurrent C. diff. infection after a course of antibiotics.
While continuing to pursue the enema-delivered version, the company says RBX7455 is a leap forward for its microbial restoration therapy because it has been designed as an orally-administered capsule that can be stored at room temperature for months at time, with no need to be frozen as is usually necessary to store living microbes.
This month it announced it has partnered with Mayo gastroenterologist Dr. Sahil Khanna on a Phase I dosing study of the orally-administered version at the Rochester clinic, with the first patient already undergoing the therapy.
Dr. Khanna, one of the leading voices in warning that C. diff. infections have reached epidemic proportions in and out of the nation’s hospitals, staffs a clinic devoted to the problem that opened within Mayo in 2013.
“C. difficile is a hospital-acquired infection that's now out in the community,” he said at the time of the clinic’s establishment. “It's getting more severe and harder to treat. We think a clinic that's dedicated to the management of these patients, that's staffed by experienced physicians and a whole team of study coordinators, nurses and researchers in the microbiome field who have a vested interest in C. diff., will help improve patient outcomes.”
The C. diff. clinic has performed fecal transplants on patients with a recurrent form of the infection, which have been carried out via colonoscopies. Rebiotix’s lead drug, RBX2660, is a bid to replace the invasive colonoscopies with a much-less taxing enema. A viable orally administered capsule would be the next step.
“New therapies are urgently needed to prevent recurrent C. diff., a debilitating, costly and potentially life-threatening infection,” Khanna said in a release announcing the new clinical trial. “RBX7455 not only provides standardized and stabilized human microbes orally, but may provide several advantages in terms of patient dosing and therapy accessibility since no freezing or refrigeration is needed when the patient takes the product home.”
Rebiotix, led by President and CEO Lee Jones, counts among its investors such Minnesota health care heavyweights as former UnitedHealth Group CEO and Minnesota United FC owner William McGuire, venture capitalist Erwin Kelen, and former Boston Scientific exec Michael Berman.
It touts itself as “the most clinically advanced microbiome company in the industry.“