SHM Converge Scientific Abstract ePoster Gallery-EFFICACY OF INVESTIGATIONAL MICROBIOTA-BASED LIVE BIOTHERAPEUTIC RBX2660 IN<br /><br />individuals WITH RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: DATA FROM 5<br /><br />prospective CLINICAL STUDIES

EFFICACY OF INVESTIGATIONAL MICROBIOTA-BASED LIVE BIOTHERAPEUTIC RBX2660 IN

individuals WITH RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: DATA FROM 5

prospective CLINICAL STUDIES

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This conference abstract summarizes results from five prospective clinical studies of RBX2660, a microbiota-based live biotherapeutic designed to reduce recurrent <em>Clostridioides difficile</em> infection (rCDI). RBX2660 is manufactured under standardized quality controls and donor screening procedures, with the goal of providing a safe, effective microbiome-based therapy for patients who recur after standard antibiotic treatment.

The studies enrolled adults with documented rCDI who had completed standard-of-care antibiotics before receiving RBX2660. Treatment success was defined as remaining free of recurrence for 8 weeks after treatment, with longer follow-up lasting at least 6 months and up to 24 months in some trials. In most studies, participants who did not respond initially could receive a second open-label course.

Across more than 700 treated patients, RBX2660 consistently reduced CDI recurrence. In open-label studies, treatment success ranged from 50.0% to 78.9%. In the randomized PUNCH CD2 trial, treatment success was similar with 1-dose and 2-dose RBX2660 (56.8% and 55.6%) and higher than placebo (43.2%). In the larger PUNCH CD3 trial, model-estimated success was 70.4% for RBX2660 versus 58.1% for placebo, showing significant superiority.

A second treatment course further improved outcomes in initial nonresponders, with success rates between 50.0% and 78.6%, and overall success rates rising to 75.0%–84.4% in some groups. Most responders remained CDI-free through 6 months, and the benefit over placebo persisted over time.

Overall, the data suggest RBX2660 provides a consistent and durable reduction in rCDI, including in patients who recur after an initial dose.

Asset Subtitle

Adam Harvey

Meta Tag

Author List Adam Harvey, Lindy Bancke, Xin Su

Category Research

Concept Clostridioides difficile Infection

Concept Recurrent Clostridioides difficile infection

Concept RBX2660

Concept Microbiome-directed Therapy

Concept Clinical Trial

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 therapy

live biotherapeutic

clinical trials

placebo-controlled trial

treatment success

recurrence prevention

microbiome therapy

Clostridioides difficile Infection

Recurrent Clostridioides difficile infection

RBX2660

Microbiome-directed Therapy

Clinical Trial