What is the study drug?
The investigational treatment, called CP101, is a capsule designed to deliver a full community of beneficial bacteria to the areas of the intestine affected by C. difficile. The study drug, like fecal microbiota transplantation (FMT), is intended to restore the ecosystem found in a healthy human gut. But unlike traditional fecal transplants, which usually involve colonoscopies or enemas, CP101 is an odorless capsule taken orally.
How could the microbiome help?
Many C. difficile infections occur after a patient has taken antibiotics. While antibiotics can help us, they can also harm the beneficial ecosystem that protects us against infections like C. difficile. This disruption of the “microbiome” – the community of bacteria that live in our gut – is one reason why it is common for C. difficile to recur after the initial infection. Restoring the microbiome to a healthy balance may help break this cycle of recurrence.
How is the study drug designed to work?
The investigational treatment, CP101, is a capsule containing a freeze-dried community of bacteria from a healthy human gut. It is designed to deliver this new microbiome to the specific areas of the intestine that have been disrupted by C. difficile and antibiotics.
Who is the sponsor?
The PRISM 3 study is sponsored by Finch Research and Development, LLC. We were founded 6 years ago with the mission of developing a long-term solution to recurrent C. difficile, after seeing loved ones suffer from the infection. Please visit finchtherapeutics.com to learn more.