PUNCH™ CD 2 Study: A Clinical Trial For The Treatment Of Recurrent Clostridium difficile Infection Is Currently Enrolling Patients
The PUNCH™ CD 2 study, sponsored by Rebiotix Inc., is open for enrollment and actively recruiting patients. This study represents Rebiotix progress toward developing and commercializing a new therapy to treat patients with recurrent episodes of Clostridium difficile infection.
The PUNCH CD 2 study is a multi-center, randomized, double-blind placebo-controlled trial of Rebiotix lead candidate RBX2660 (microbiota suspension) for the treatment of recurrent CDI and represents the most rigorous clinical study of fecal transplants to date. In this study, the patients may get the microbiota-based drug or may get a placebo. Neither the doctor nor the patients know what treatment is received in order to get an unbiased measurement of the drug’s true effectiveness. If a patient’s CDI symptoms return, even if they are in the placebo arm of the study, they may be eligible to receive RBX2660. This is referred to as the open-label portion of the study.
The PUNCH CD 2 study follows quickly on the heels of Rebiotix’s successful PUNCH CD study. The PUNCH CD trial, which was a Phase 2 open label safety and preliminary efficacy study, was successfully completed in July 2014. An open label study means everyone enrolled in the study got the treatment and it is generally the first phase of a new product development program. The study demonstrated a success rate of 87% for those treated with no serious adverse events related to either the product or the method of delivery. For more PUNCH CD study results go to: http://www.talkcdiff.com/punch-cd-2-clinical-trial-for-c-diff/punch-cd-clinial-trial-results/
For additional information on the PUNCH CD 2 study including participation go to: https://www.talkcdiff.com/punch-cd-2-clinical-trial-for-c-diff/
https://clinicaltrials.gov/ct2/show/NCT02299570/
“It is said that the most profound gift is that which is given anonymously, without assurances of any direct personal benefit. This is the gift of participation in clinical research.”
-Ken Getz