SHM Converge Scientific Abstract ePoster Gallery-Rbx2660 in Patients After First Recurrence of Clostridioides Difficile Infection

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This post hoc analysis of the phase 3 PUNCH CD3 trial evaluated fecal microbiota, live-jslm (FMBL), a single-dose rectal microbiota-based live biotherapeutic approved to prevent recurrent Clostridioides difficile infection (rCDI), in participants who had experienced only one prior rCDI episode before enrollment.<br /><br />Among the modified intent-to-treat population, 86 of 262 participants had a first recurrence before treatment. They were mostly White (93%), female (66%), and had a mean age of about 58 years. Participants received either FMBL or placebo after completing standard antibiotic therapy.<br /><br />Efficacy results favored FMBL. At 8 weeks, 79.2% of FMBL-treated participants achieved treatment success, defined as being free of CDI recurrence, compared with 60.6% of placebo-treated participants. Among those who were treatment successes at 8 weeks, durability of response through 6 months was high in both groups: 90.5% for FMBL and 85.0% for placebo.<br /><br />Safety findings were generally similar between groups and consistent with a mild-to-moderate adverse event profile. Treatment-emergent adverse events occurred in 54.7% of FMBL-treated participants versus 33.3% of placebo-treated participants, with the difference driven mainly by mild gastrointestinal events such as diarrhea and abdominal pain. Serious adverse events were uncommon and comparable (5.7% FMBL, 6.1% placebo). No potentially life-threatening events, discontinuations due to adverse events, or deaths were reported.<br /><br />Overall, the analysis supports the efficacy and safety of FMBL in preventing rCDI even as early as the first recurrence.

Asset Subtitle

Beth Guthmueller

Meta Tag

Author List Beth Guthmueller, Glenn Tillotson, Kerry LaPlante, Kevin W. Garey, Lindy Bancke, Masakazu Ando, Sahil Khanna

Category Research

Concept Fecal Microbiota Live-jslm

Concept Clostridioides difficile Infection

Concept Recurrent Clostridioides difficile infection

Concept First Recurrence

Concept Treatment Success

Distinguished Non-Finalist

Presenter Organization Rebiotix Inc.

Presenting Author Beth Guthmueller

Track Outcomes Research

Keywords

fecal microbiota live-jslm

FMBL

Clostridioides difficile infection

recurrent CDI

phase 3 PUNCH CD3 trial

post hoc analysis

treatment success

placebo comparison

microbiota-based biotherapeutic

safety and efficacy

Fecal Microbiota Live-jslm

Clostridioides difficile Infection

Recurrent Clostridioides difficile infection

First Recurrence

Treatment Success