Rebiotix Inc., a Ferring Company, has conducted several trials of the lead microbiota-based product in the MRT™ drug platform, RBX2660, for reducing the rate of recurrence of Clostridioides difficile infection. RBX2660 is currently under study in a Phase 3 clinical trial in conjunction with the US Food and Drug Administration’s Investigational New Drug application, as well as the Clinical Trial Application (CTA) of HealthCanada. The following sections outline the studies conducted to date:
Study: PUNCH CD3-OLS (Currently Enrolling)
About
The PUNCH CD3-OLS study is a Phase 3 clinical study to assess the safety and tolerability of Rebiotix RBX2660 for the prevention of recurrent Clostridioides difficile infection (CDI) in a recurrent CDI population that is broader and more inclusive than that included in prior studies using RBX2660.
- Prospective, multi-center, open label Phase 3 study
- Enrolling up to 600 patients at approximately 80 research sites
- Primary efficacy endpoint: Assess the efficacy of RBX2660 defined as no CDI recurrence at 8 weeks
- Primary Safety endpoint: Assess the safety of RBX2660 to 6 months
Detailed Information & Site Locations
Visit: clinicaltrials.gov
Study Participation
Email: US8-StudyInfo@nullferring.com
Study: PUNCH CD3 (Active, Not Enrolling)
About
The PUNCH CD3 study is a Phase 3 clinical study to evaluate the safety and efficacy of Rebiotix RBX2660 for the prevention of recurrent Clostridioides difficile infection (CDI).
- Prospective, randomized, double-blind, placebo-controlled study
- Enrolling up 270 patients at approximately 60 research sites in US and Canada
- Randomized to receive RBX2660 or placebo (2:1)
- Primary efficacy endpoint: Assess the efficacy of RBX2660 defined as no CDI recurrence at 8 weeks as compared to placebo
- Primary safety endpoint: Assess the safety of RBX2660 to 6 months
Detailed Information & Site Locations
Visit: clinicaltrials.gov
Study: PUNCH Open Label (Completed)
About
- Prospective, multicenter, open-label, controlled Phase 2 study
- Primary efficacy endpoint involved a comparison of patients treated with RBX2660 to a closely matched set of antibiotic only treated historical controls through 56 days
- 31 active treatment sites and four control sites in the U.S. and Canada.
- 132 RBX2660 and 110 historical control subjects were included in this topline analysis
Results
Study: PUNCH CD2 (Completed)
About
- Phase 2B, prospective, multi-center randomized double-blind, placebo-controlled with 2-year follow-up
- Primary efficacy objective: Assess the efficacy of RBX2660 vs. placebo defined as no CDI recurrence at 8 weeks
- Primary safety objective: Assess the safety of RBX2660
- A total of 120 patients enrolled at 21 sites in the U.S. and Canada
- Patients were randomized into 3 treatment arms
Results
Study: PUNCH CD (Completed)
About
- Phase 2 prospective multi-center, open-label study with 6-month follow-up
- Primary objective: Assess the safety of RBX2660
- Secondary objective: Efficacy defined as no CDI recurrence at 8 weeks
Results
- Forty patients were enrolled at 11 centers in the US; a total of 31 patients completed 6-month follow-up.
- Overall efficacy was 87.1% (27/31).
- Safety: Most commonly reported AEs were mild to moderate diarrhea, flatulence, abdominal pain/cramping and constipation and were self-limiting.
- Twenty serious AEs were reported in 7 patients; none were related to RBX2660 or its administration.
- Results on clinicaltrials.gov
- Results published November, 2015
Conclusions
- RBX2660 demonstrated a satisfactory safety profile in a Phase 2 study targeted at recurrent CDI which included a rigorous, independent assessment of AEs.
- Overall efficacy of 87.1% is in line with previously reported results.