Could lead to the development of a new class of drugs based on the human microbiome
The purpose of the PUNCH CD study is to assess the safety of RBX2660 (microbiota suspension) for the treatment of recurrent Clostridium difficile-associated diarrhea (CDAD).
What is CDAD?
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 Clostridium difficile bacteria is CDAD.
What is RBX2660?
RBX2660 is a preparation of live microbes that is being studied to see if it safely treats recurrent CDAD.
Similar microbial treatments have been used in the past, but RBX2660 is the first standardized and commercially prepared microbiota restoration therapy (MRT) for the treatment of recurrent CDAD. 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.
PUNCH CD is an open-label, non-randomized study. That means that all clinicians and patients in the study will know that RBX2660 is being given and that all patients in the study will receive RBX2660. Approximately 40 patients will be enrolled in the study, which will continue until all patients have completed six months of follow-up.
Which Healthcare Centers are Participating?
Approximately 20 centers in the US and Canada are participating in the study.
Who is Eligible to Participate?
In brief, the target patient population is adults (≥ 18 years old) with recurrent CDAD who have had:
• At least two recurrences of CDAD (at least three episodes) and have completed at least two rounds of oral antibiotic therapy.
• Have had at least two episodes of severe CDAD resulting in hospitalization.
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
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. Lead product RBX2660 is targeted at recurrent Clostridium difficile, a life-threatening largely hospital-acquired infection.
Visit Rebiotix on the Web at: http://www.rebiotix.com
*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.