RECURRENT C. DIFFICILE
Finch’s lead therapeutic candidate, CP101, is an investigational Full-Spectrum Microbiota product for prevention of recurrent C. difficile infections (CDI or C. diff).
About C. Difficile INFECTIONS (CDI)
CDI is a common bacterial infection causing patients to suffer from diarrhea, fever nausea, and abdominal pain. The Centers for Disease Control (CDC) has named CDI an urgent public health threat and the leading hospital-acquired infection in the U.S. Besides its enormous human toll, CDI drives significant costs due to extensive hospitalizations. Historically, standard-of-care antibiotic treatment presents a risk of recurrence in approximately 60% of patients who have experienced multiple recurrences, highlighting a clear unmet medical need. Patients who have already failed multiple rounds of antibiotics are especially susceptible to a recurrence of CDI as many of their beneficial bacteria have been eliminated.
CP101 is an orally-administered investigational product designed to break the cycles of infection by restoring the balance of the gut microbiome, an approach supported by numerous clinical studies and Finch’s extensive experience providing microbial treatments to patients suffering from C. diff.
A prototype formulation of CP101 showed a clinical success rate of 88% (defined as no recurrence of CDI over 2 months) in a proof of-concept study conducted by Finch’s collaborators, Drs. Alexander Khoruts and Michael Sadowsky at the University of Minnesota (Staley, 2017). Furthermore, patients’ microbial communities achieved near normalization within one month following treatment.
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CP101 for the treatment of patients with recurrent CDI. Breakthrough Therapy designation is intended to expedite the development and review of investigational therapeutics for serious or life-threatening conditions where preliminary clinical evidence indicates that the product may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints.
CP101 is currently being studied in the PRISM 3 trial for recurrent CDI.
ABOUT THE PRISM 3 STUDY FOR RECURRENT C. DIFF
PRISM 3 is a clinical study evaluating the safety and efficacy of CP101 compared to a placebo in treating recurrent C. diff. PRISM 3 will enroll approximately 200 subjects at clinical sites throughout the U.S. and Canada.
CP101 is an investigational drug, meaning it has not yet been approved by the US Food and Drug Administration for treating recurrent C. diff infections.