Interim Analysis of a Phase 3 Open-Label Study Indicates Safety and Efficacy of RBX2660, an Investigational Live Biotherapeutic, in a “Real-world” Population of Patients with Recurrent Clostridioides difficile Infection

Colleen Kraft MD¹, Sahil Khanna MBBS², Maha Assi MS MPH³, Paul Feuerstadt MD⁴, Adam Harvey PhD⁵, Lindy Bancke PharmD⁵
¹Emory University, Atlanta, GA, USA; ²Mayo Clinic, Rochester, MN, USA; ³Infectious Disease Consultants, Wichita, KS, USA; ⁴Gastroenterology Center of Connecticut, Hamden, CT, USA; ⁵Rebiotix Inc, Roseville, MN, USA

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Microbiota-restoring approaches are being widely evaluated for treatment of recurrent Clostridioides difficile infections (rCDI) in controlled clinical studies.
Eligibility criteria in clinical trials of investigational treatments are often narrowly defined, with rigid diagnostic criteria and exclusion of patients with potentially confounding co-morbid conditions, such as Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS).
RBX2660, an investigational microbiota-based formulation, has shown efficacy in preventing rCDI through 8 weeks in several previous clinical trials, including two randomized, placebo-controlled studies (NCT02299570; NCT03244644).
Herein we report an interim analysis of PUNCH CD3-OLS, a Phase 3 open-label study evaluating the safety and efficacy of RBX2660 in the reduction of rCDI recurrence (NCT03931941).
PUNCH-CD3-OLS eligibility criteria is less restrictive to allow evaluation in a population more typical of real-world rCDI clinical practice.

RBX2660 demonstrated safety and efficacy under real world conditions for reduction of rCDI in adult participants following antibiotic therapy with a consistent and favorable safety profile for single or multiple doses of RBX2660.
These interim results replicate the safety and efficacy profile demonstrated in previous studies of RBX2660, contributing to the preponderance of evidence compiled over the formulation’s development program.
Furthermore, the observed RBX2660 safety and efficacy profile in a population inclusive of participants with IBD and IBS demonstrates that previously established results for RBX2660 remain robust in a broader population more typical of real-world rCDI clinical practice.
This study is ongoing and continues to enroll subjects.