From my afternoon reading feed: “Ferring and Rebiotix Present Landmark Phase 3 Data Demonstrating Superior Efficacy of Investigational RBX2660 Versus Placebo to Reduce Recurrence of C. difficile Infection.” They presented the research today at Digestive Disease Week 2021. This is very exciting!
Some key points:
➡️ “Findings build on previous RBX2660 clinical trials showing repeated efficacy and consistent safety, including two trials with two years of safety follow-up.”
➡️ “These Phase 3 RBX2660 results, as part of the overall clinical development program, show consistent efficacy as early as a first recurrence of C. difficile infection by delivering a broad consortium of live microbes to the area of active infection.”
➡️ “RBX2660 is a potential first-in-class microbiota-based live biotherapeutic being studied to deliver a broad consortium of diverse microbes to the gut to reduce recurrent C. difficile infection.”
➡️ “RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA). The pivotal Phase 3 program builds on nearly a decade of research with robust clinical and microbiome data collected over six controlled clinical trials with more than 1,000 participants.”
➡️ “The findings from this pivotal Phase 3 trial of RBX2660 are very encouraging to both patients and healthcare providers, providing hope this potential new treatment could make a meaningful difference in the lives of patients with recurrent C. difficile infection.”