How may we assist you? (select one/required) I am interested in participating in the Phase 3 study for the prevention of recurrent C. difficile infection. I am interested in participating in other areas of microbiome clinical research.
The PUNCH CD3 clinical research study is a Phase 3 Study to evaluate Rebiotix RBX2660 (microbiota suspension) for the prevention of recurrent Clostridium difficile infection (CDI).
PUNCH CD3 is currently active and enrolling at several locations across the United States and Canada. This is the fourth clinical study evaluating RBX2660 for recurrent CDI and all studies have been filed with FDA as part of an investigational new drug application.
Study treatment consists of a single blinded enema of RBX2660 or placebo according to the 2 to 1 randomization assignment. Study patients who are deemed treatment failures following the blinded treatment may elect to receive an unblinded (active) RBX2660 study drug treatment.
Primary efficacy endpoint is the recurrence of CDI within 8 weeks of blinded treatment. Secondary safety and efficacy endpoints are evaluated through 6 months.
At least two episodes of severe CDI resulting in hospitalization within the last year.
A positive stool test for the presence of C. difficile within 30 days prior to or on the date of study enrollment.
Study candidates must currently be taking or have just been prescribed antibiotics to control recurrent CDI symptoms at the time of enrollment. Additional PUNCH CD3 study information including a complete list of inclusion and exclusion criteria is available at clinicaltrials.gov.
Lead candidate RBX2660 is a standardized, stabilized microbiota-based drug created from a broad consortium of spore and non-spore forming microbes. RBX2660 is prepared from thoroughly screened healthy human donors and is administered by ready-to-use enema.
RBX2660 has previously been studied in three Phase 2 regulated clinical studies and has been granted Fast Track status, Orphan Drug and Breakthrough Therapy designation from the FDA for its potential to prevent recurrent CDI.
Rebiotix Inc. is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com.