Finch -Model CP101 -Microbiome Therapeutics for Recurrent C. Difficile Infection (CDI)
Our lead product candidate, CP101, is an orally administered, Complete Consortia product candidate initially targeting the prevention of recurrent CDI. The Centers for Disease Control and Prevention considers CDI to be one of the top three most urgent antibiotic resistant threats and the most common cause of healthcare associated infection in the United States.
The Unmet Need
C. difficile is a gastrointestinal pathogen that can cause severe, persistent, and potentially life-threatening inflammation of the colon and diarrhea
>450,000 cases of primary CDI and approximately 200,000 cases of recurrent CDI annually in the US, collectively resulting in more than 44,000 CDI-attributable deaths per year
Recent antibiotic use disrupts the microbiome and puts individuals at risk for developing recurrent CDI
The current standard of care for recurrent CDI is antibiotic therapy, which leads to high rates of recurrence as antibiotics fail to address the underlying microbiome disruption that leads to recurrence
There is an urgent unmet need for a drug that restores the microbiome and breaks the cycle of recurrence early
Oral delivery of a lyophilized, intact microbiome community harvested from rigorously screened healthy, human donors and formulated in capsules designed to release at the appropriate location in the gastrointestinal tract
Designed to prevent recurrent CDI by restoring microbiome diversity, addressing the dysbiosis that leads to recurrence
CP101 met its primary efficacy endpoint in PRISM3, the first of two planned pivotal, randomized, placebo-controlled, multi-center trials in recurrent CDI — overall, 74.5% of participants who received a single administration of CP101 achieved a sustained clinical cure, defined as the absence of CDI through week 8, achieving statistical significance for the primary efficacy endpoint, with a clinically meaningful 33.8% relative risk reduction for CDI recurrence compared to placebo
CP101 is the only orally administered, microbiome therapeutic candidate drug in development that achieved its primary endpoint in a pivotal trial that included patients across all stages of recurrent CDI, including first recurrence
Awarded Fast Track and Breakthrough Therapy designations by the FDA for the prevention of recurrent CDI