Rebiotix and Ferring announced positive preliminary findings from a phase 3 study of RBX2660 for the prevention of recurrent Clostridioides difficile infection.
RBX2660, a microbiome-based therapy, delivers human-derived microbes via an enema into a patient’s intestinal tract. Studies have shown that most C. difficile infection (CDI) cases occur after antibiotics disrupt the normal gastrointestinal flora. The Company believes RBX2660 will reduce CDI recurrences by restoring the gut microbiome.
The ongoing randomized, double-blind, placebo-controlled PUNCH CD3 study is assessing the safety and efficacy of RBX2660 in patients with at least 1 recurrence of CDI after a primary episode, who completed at least 1 round of standard of care oral antibiotic therapy or had at least 2 episodes of severe CDI resulting in hospitalization within the previous year.
Patients are randomized 2:1 to receive either RBX2660 or placebo. The primary end point is the proportion of patients with treatment success at week 8, defined as the absence of C. difficile diarrhea without the need for retreatment. Secondary end points include an assessment of adverse events and Health Related Quality of Life (HRQOL) scores.
Full detailed results are anticipated in the second half of 2020.
“These positive preliminary findings represent a major step forward towards bringing an innovative, non-antibiotic option to patients that may help restore their gut microbiome,” said Per Falk, Ferring’s President and Chief Science Officer. “With health systems under increasing pressure due to viruses like COVID-19 and the rising threat of antimicrobial resistance, the need for new therapies is greater than ever. We believe the power of the microbiome has great potential and we look forward to bringing RBX2660 to patients soon.”
The Food and Drug Administration (FDA) previously granted Fast Track, Orphan Drug, and Breakthrough Therapy designations to RBX2660 for this indication.