SHM Converge Scientific Abstract ePoster Gallery-Microbiota-Based Biotherapeutic Rbx2660 Improves Clostridioides Difficile Infection Outcomes in a Real-World Population: A Retrospective Study of Use Under Enforcement Discretion

Microbiota-Based Biotherapeutic Rbx2660 Improves Clostridioides Difficile Infection Outcomes in a Real-World Population: A Retrospective Study of Use Under Enforcement Discretion

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This retrospective real-world study evaluated RBX2660, an investigational microbiota-based live biotherapeutic, in adults with recurrent Clostridioides difficile infection (rCDI) who received treatment under the FDA’s Enforcement Discretion policy. Unlike clinical trials with narrow eligibility rules, this analysis included a broader patient population from five sites between 2015 and 2019, with no exclusion criteria and treatment decisions made by site physicians.<br /><br />A total of 94 participants were included in the full analysis set, and 64 formed the primary safety set. The population was older on average, predominantly female, and had substantial prior antibiotic exposure and multiple comorbid gastrointestinal or immune-mediated conditions.<br /><br />Efficacy was strong. In the primary safety set, 82.8% of patients achieved treatment success, defined as no rCDI within 8 weeks after RBX2660. Among those who responded, 88.7% maintained a sustained clinical response at 6 months. Outcomes were similar whether patients received one or two doses.<br /><br />Safety findings were consistent with prior prospective trials. Most treatment-emergent adverse events were mild to moderate, and no serious adverse events were judged related to RBX2660 or the administration procedure. Two deaths occurred, but neither was related to treatment. Safety outcomes were comparable across subgroups with gastrointestinal, inflammatory, or autoimmune comorbidities.<br /><br />Overall, the study suggests RBX2660 is both effective and well tolerated in a real-world rCDI population with broad eligibility, supporting and extending results from earlier clinical trials.

Asset Subtitle

Adam Harvey

Meta Tag

Author List Adam Harvey, Lindy Bancke, Paul Feuerstadt

Category Research

Concept RBX2660

Concept Recurrent Clostridioides difficile infection

Concept Treatment Effectiveness

Concept Treatment Success

Concept Safety

Distinguished Non-Finalist

Presenter Organization Rebiotix Inc, a Ferring Company

Presenting Author Adam Harvey

Track Other

Keywords

RBX2660

recurrent Clostridioides difficile infection

rCDI

microbiota-based live biotherapeutic

real-world study

FDA Enforcement Discretion

treatment success

sustained clinical response

safety profile

gastrointestinal comorbidities

RBX2660

Recurrent Clostridioides difficile infection

Treatment Effectiveness

Treatment Success

Safety