SHM Converge Scientific Abstract ePoster Gallery-24-Month Sustained Outcomes of Rbx2660 for Recurrent Clostridioides Difficile Infection

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This poster reports a post hoc subgroup analysis of long-term efficacy and safety of fecal microbiota, live-jslm (FMBL), a rectally administered microbiota-based live biotherapeutic approved to prevent recurrent Clostridioides difficile infection (rCDI) after antibiotic treatment. The study used data from the PUNCH CD Open-Label phase 2 trial.<br /><br />Among 149 treated participants, 91% were White, 64% female, and 58% were at least 65 years old. Treatment success at 8 weeks was achieved in 78.9% of evaluable participants, with subgroup success rates ranging from 67% to 85%. Participants with four or more prior CDI episodes still had an 83% success rate. <br /><br />For those who responded at 8 weeks, sustained response remained high over time: 97% at 6 months, 95% at 12 months, and 91% at 24 months overall. Similar durable responses were observed across age, sex, race, and number of prior CDI episodes. In older participants, sustained response remained 98.0% at 6 months, 97.9% at 12 months, and 93.5% at 24 months for the 65+ subgroup.<br /><br />Safety findings were reassuring. Most treatment-emergent adverse events occurred within the first 4 weeks after treatment. Later adverse events were reported at comparable rates across subgroups between 6 and 12 months and between 12 and 24 months. No infections were traced to FMBL, and no evidence of new disease related to treatment emerged over 2 years of follow-up.<br /><br />Overall, the analysis suggests that FMBL provides durable protection against rCDI recurrence and is well tolerated across demographic subgroups.

Asset Subtitle

Beth Guthmueller

Meta Tag

Author List Beth Guthmueller, Christine Lee, Erik R. Dubberke, Gail Hecht, Glenn Tillotson, Kerry LaPlante, Masakazu Ando, Robert Orenstein, Samson Ng

Category Research

Concept Fecal Microbiota Live-jslm

Concept Clostridioides difficile Infection

Concept Recurrent Clostridioides difficile infection

Concept Treatment Success

Concept Sustained Clinical Response

Distinguished Non-Finalist

Presenter Organization Rebiotix Inc.

Presenting Author Beth Guthmueller

Track Outcomes Research

Keywords

fecal microbiota live-jslm

FMBL

recurrent Clostridioides difficile infection

rCDI

post hoc subgroup analysis

long-term efficacy

sustained response

safety profile

microbiota-based live biotherapeutic

PUNCH CD Open-Label trial

Fecal Microbiota Live-jslm

Clostridioides difficile Infection

Recurrent Clostridioides difficile infection

Treatment Success

Sustained Clinical Response