This is the first multi-center study of a next-generation fecal transplant. The PUNCH™ CD study, sponsored by Rebiotix Inc., has completed enrollment. This study represents Rebiotix’s progress toward developing and commercializing a new non-antibiotic, therapy to treat patients with recurrent episodes of debilitating and potentially life-threatening Clostridium difficile infection (CDI). The purpose of the PUNCH CD study is to assess the safety of RBX2660, an upgraded version of fecal transplant (FT) therapy for the treatment of recurrent Clostridium difficile infection. Secondary objectives of the study include gathering information on the efficacy and cost-effectiveness of the therapy. A total of 40 patients at 13 centers across the United States were enrolled. Now that enrollment is complete, the study will continue until all follow-up data is collected. Rebiotix is currently working on a protocol for a randomized multicenter Phase 3 study to further evaluate this new therapy.
What is CDI?
Symptoms of Clostridium difficile infection include profuse watery diarrhea, abdominal pain and tenderness, fever and loss of appetite. The term for the diarrhea resulting from CDI is Clostridium difficile-associated (CDAD).
What is RBX2660?
RBX2660 is a preparation of live microbes that is being studied to see if it safely treats recurrent CDI. Similar microbial treatments have been used in the past, but RBX2660 is the first standardized and commercially prepared next generation fecal transplant therapy for the treatment of recurrent CDI. As such, it represents a milestone in translating knowledge about the human microbiome into a drug for human use.
Why is the PUNCH CD Study Important?
Although clinicians have prepared similar products using a variety of methods to treat recurrent Clostridium difficile infection for many years, the PUNCH CD study is the first time that a standardized commercially manufactured biological drug containing live microbes is being evaluated.
Why Participate in a Clinical Study?
People participate in clinical studies for many reasons. These include having the opportunity to: • Receive a new, potentially helpful, research treatment before it is available commercially. • Receive care at a leading healthcare center during the study. • Help others with a similar condition. • Help advance medical knowledge.
Where can I Learn More?
Additional information on the PUNCH CD study can be found at: http://www.clinicaltrials.gov/ct2/show/NCT01925417?term=Rebiotix&rank=1 About Rebiotix Rebiotix Inc. is a biotechnology company founded to revolutionize the treatment of challenging gastrointestinal diseases by harnessing the power of the human microbiome. The company has developed a unique biopharmaceutical platform called Microbiota Restoration Therapy (MRT) to restore healthy gut flora through the transplantation of live microorganisms. Visit Rebiotix on the Web at: www.rebiotix.com