Robert Orenstein, Erik R. Dubberke, Sahil Khanna, Christine H. Lee, David Yoho, Stuart Johnson, Gail Hecht, Herbert L. DuPont, Dale N. Gerding, Ken F. Blount, Sarah Mische and Adam Harvey Background Effective treatment options for recurrent Clostridioides difficile infection (rCDI) are limited, with high recurrence rates associated with the current standard of care. Herein we report results […]
Journal Articles
Development and Validation of a Novel Microbiome-Based Biomarker of Post-antibiotic Dysbiosis and Subsequent Restoration
Ken Blount1*, Courtney Jones1, Dana Walsh1, Carlos Gonzalez2 and William D. Shannon21Rebiotix Inc., a Ferring Company, Roseville, MN, United States, 2BioRankings LLC, St. Louis, MO, United States Background The human gut microbiota are important to health and wellness, and disrupted microbiota homeostasis, or “dysbiosis,” can cause or contribute to many gastrointestinal disease states. Dysbiosis can be caused by many factors, […]
RBX7455, a Non-frozen, Orally Administered Investigational Live Biotherapeutic, Is Safe, Effective, and Shifts Patients’ Microbiomes in a Phase 1 Study for Recurrent Clostridioides difficile Infections
Sahil Khanna, Darrell S Pardi, Courtney Jones, William D Shannon, Carlos Gonzalez, Ken Blount Background Recurrent Clostridioides difficile infections (rCDI) are a global public health threat. To reduce rCDI, microbiota-restoring therapies are needed, particularly standardized, easy-to-administer formulations. Methods This phase I open-label trial assessed the safety, efficacy in preventing rCDI recurrence, and intestinal microbiome effects of RBX7455, a room temperature-stable, orally administered […]
The effect of microbiota-based investigational drug RBX2660 on the gut microbiome and resistome revealed by a placebo-controlled clinical trial
Suryang Kwak1, JooHee Choi1, Tiffany Hink1, Kimberly A. Reske1, Kenneth Blount2, Courtney Jones2, Margaret H. Bost1, Xiaoqing Sun1, Carey-Ann D. Burnham1, Erik R. Dubberke1, Gautam Dantas11Washington University in Saint Louis School of Medicine, 2Rebiotix Inc Abstract Background Intestinal microbiota restoration can be achieved by replacing a subject’s perturbed microbiota with that of a healthy donor. […]
Restoration of Bacterial Microbiome Composition and Diversity Among Treatment Responders in a Phase 2 Trial of RBX2660: An Investigational Microbiome Restoration Therapeutic
Ken F. Blount,1 William D. Shannon,2 Elena Deych,2 and Courtney Jones,1 1Rebiotix, Roseville, Minnesota; 2BioRankings, St Louis, Missouri Background RBX2660 is an investigational microbiota restoration therapy in phase 3 clinical development for preventing recurrent Clostridioides difficile infections (CDIs). In a randomized, double-blinded placebo-controlled phase 2B trial, RBX2660 was effective at preventing CDI recurrence. The current study was performed to characterize the […]