RBX2660 (microbiota suspension) for Recurrent C. difficile Infection: 60-Day Interim Analysis of the PUNCH-CD Phase 2 Safety Study
Methods: Patients with recurrent CDI, defined as at least 3 CDI episodes or at least 2 severe episodes resulting in hospitalization, were enrolled. All patients received treatment with RBX2660 (microbiota suspension) administered via enema. A second treatment was permitted if CDI recurred in < 8 weeks after the first treatment. Follow-up was at 7, 30 and 60 days and 3 and 6 months after the last treatment. The primary objective was the product-related adverse events (AEs). A secondary objective was CDI resolution.
Results: Of the 40 patients enrolled at 11 centers in the US, 34 patients (mean age 66.8 years, 67.6% female) received at least one treatment. Thirty-one patients were included in a 60-day interim analysis. A total of 158 AEs were elicited in 29 patients. AEs were predominantly mild to moderate and included flatulence, belching, constipation, and occasional bouts of diarrhea. There were 9 serious AEs reported in 6 patients (3 recurrent CDI ≤ 8 weeks days post-treatment, all of which required hospitalization; 1 case of pneumonia; 1 pelvic fracture; 1 stab wound; 1 chronic obstructive pulmonary disease; 1 pulmonary edema and 1 respiratory failure). None of the serious AEs was related to RBX2660 or its administration. Efficacy of RBX2660 defined as the absence of CDI at 8 weeks after the last dose was 87.1%.
Conclusion: RBX2660 was well-tolerated and demonstrated satisfactory safety in a 60-day interim analysis of the first prospective multi-center study of a next generation standardized, commercially prepared microbiota restoration therapy for recurrent CDI.
Rebiotix: Consultant and Investigator, Consulting fee and Research support
Sanofi Pasteur: Consultant and Investigator, Consulting fee and Grant recipient
Merck: Consultant and Grant Investigator, Consulting fee and Research support
Cubist: Consultant and Investigator, Consulting fee and Research support
Merck: Consultant and Investigator, Research support
P. Mariani, Rebiotix: Investigator, Research support
K. Mullane, Rebiotix: Research Contractor, Research support
Astellas Pharma US Inc: Research Contractor and Speaker's Bureau, Research support
Ason Pharmaceuticals: Research Contractor, Research support
Chimerix: Research Contractor and Scientific Advisor, Research support
Cubist / Optimer: Research Contractor and Scientific Advisor, Consulting fee and Research grant
Merck Sharp & Dohme Corp: Research Contractor and Scientific Advisor, Consulting fee and Research support
ViroPharma: Research Contractor, Research support
Pfizer: Research Contractor, Research support
M. K. Sobcinski, Rebiotix Inc: Employee, Salary