Ken Blount PhD, Courtney Jones BS, Sharina Carter PhD, Elena Deych MS, Bill Shannon PhD MBA Background Because Clostridium difficile infections (CDI) are strongly associated with dysbiosis, or disruption of a healthy microbiome, there are several clinical development programs in progress to develop FDA-approved microbiome-based drugs. However, quantitative biomarkers for microbiome dysbiosis and/or restoration have not been […]
Abstracts
A Prototype Biomarker for Microbiome Rehabilitation in Patients with Clostridium difficile Infections: Application to a Clinical Trial of a Lyophilized, Non-Frozen, Oral, Microbiota-Based Drug RBX7455
Ken Blount PhD, Courtney Jones BS, Sahil Khanna MBBS, Elena Deych MS, Bill Shannon PhD MBA Background Recurrent Clostridium difficile infections (rCDI) are strongly associated with dysbiosis—disruption of a healthy intestinal microbiome We have developed two forms of Microbiota Restoration Therapy™: RBX7455 is a first-of-its-kind room temperature stable, orally administered MRT; and RBX2660, a ready […]
A Lyophilized, Non-Frozen, Oral Microbiota-Based Drug RBX7455 is Safe, Reduces Clostridium difficile Infection Recurrence, and Restores the Microbiome
Sahil Khanna MBBS, Darrell S. Pardi MD, Dale N. Gerding MD, Ken Blount PhD, Courtney Jones, Bill Shannon PhD MBA, Elena Deych MS Background Microbiota-based therapies are demonstrating efficacy in preventing recurrent Clostridium difficile infections (rCDI). RBX7455 is a first-of-its-kind, lyophilized, non-frozen, orally-administered microbiota-restoring drug candidate that was developed for ease-of-use for rCDI patients. Herein […]
Developing Microbiome Rehabilitation Biomarkers for Clostridium Difficle Infections: Continued Evaluation of a Prototype MICROBIOME HEALTH INDEX™ (MHI™)
Ken Blount PhD, Courtney Jones BS, Elena Deych MS, Bill Shannon PhD MBA Background Dysbiosis, or disruption of a healthy microbiome, is strongly associated with Clostridium difficile infections (CDI). RBX2660 is a standardized, stabilized microbiota restoration therapy in clinical development for preventing recurrence of CDI (rCDI). In two recent Phase 2 clinical trials, RBX2660, a standardized, stabilized […]
Developing Microbiome Rehabilitation Biomarkers for Clostridium difficile Infections: Evaluation of a Prototype MICROBIOME HEALTH INDEX™
Ken Blount PhD, Courtney Jones BS, Elena Deych MS, Bill Shannon PhD, MBA Background Dysbiosis, or disruption of a healthy microbiome, is strongly associated with Clostridium difficile infections (CDI) There are several clinical development programs in progress to develop FDA approved microbiome-based drugs. However, quantitative biomarkers for microbiome dysbiosis and/or restoration have not been established. […]