CP101: A FULL-SPECTRUM MICROBIOTA™ PRODUCT
Finch’s platform builds off of robust scientific evidence, and leverages the principles of microbial ecology through Full-Spectrum Microbiota™ to restore the healthy microbiome. CP101 is an orally-administered investigational product designed to contain the full complement of functional microorganisms offering the potential to help restore a dysbiotic microbiota (or microbial imbalance).
CP101 is currently being studied in the PRISM 3 trial for recurrent Clostridium difficile (CDI or C. diff) infection.
Simpler, more convenient administration via capsule that avoids conventional invasive techniques like enema, nasogastric tube, or colonoscopy.
Harnesses broad microbial diversity which may engraft in the host microbiome and restore gut flora.
Novel processing method and formulation provides stability, enhancing commercial and distribution viability.
PRISM 3: A CLINICAL TRIAL STUDYING CP101 FOR RECURRENT C. DIFFicile
PRISM 3 STUDY SUMMARY
PRISM 3 is a clinical trial evaluating the safety and efficacy of CP101 compared to a placebo in treating recurrent Clostridium difficile. PRISM 3 will enroll approximately 200 subjects at clinical sites throughout the US.
The study drug, CP101 (a FSM™ product), is an investigational drug designed to deliver bacteria to the patient’s intestine. CP101 is considered "investigational" because it has not yet been approved by the US Food and Drug Administration for treating C. diff infection.