Pipeline

A diverse pipeline
of assets
targeting major
unmet needs

Leveraging our Human-First Discovery platform,

we are developing a novel class of orally administered biological drugs with the potential to restore microbiome functionality and resolve conditions driven by microbiome disruption.

Recurrent C. difficile infection (CDI)

Our lead product candidate, CP101, is an investigational orally administered, Complete Consortia therapeutic initially targeting the prevention of recurrent CDI.

The Centers for Disease Control and Prevention considers CDI to be one of the top five 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

CP101 for Recurrent CDI

  • Oral delivery of a lyophilized, diverse 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 disruption that can lead 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 following standard-of-care (SOC) antibiotics were without CDI recurrence 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 participants who received placebo following SOC antibiotics
  • CP101 is the only orally administered microbiome product candidate that achieved its primary efficacy 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

Autism spectrum disorder (ASD)

ASD is a behaviorally defined condition characterized by difficulties with interpersonal interaction, communication, and repetitive or restrictive patterns of behavior and activities. A subset of individuals with ASD experience significant GI symptoms, such as diarrhea and constipation. Multiple lines of evidence point to a potential link between the microbiome and ASD, including several investigator-sponsored, proof-of-principle clinical studies suggesting improvements in both GI and behavioral assessments following microbiota transplantation.

In September 2022, Finch announced the decision to suspend efforts to initiate a Phase 1 trial in ASD while the Company explores opportunities to leverage clinical data generated by ongoing third-party studies to inform its autism program strategy going forward.

Inflammatory bowel disease (IBD)

Ulcerative colitis and Crohn’s disease are the two most common types of IBD, an autoimmune condition that causes inflammation of the gastrointestinal (GI) tract. Symptoms of IBD include severe, chronic abdominal pain, diarrhea, GI bleeding, weight loss, and fatigue. The treatment options available today are ineffective for many people living with IBD.

With multiple lines of evidence pointing to the potential role of the microbiome in IBD, Finch has designed FIN-524 for ulcerative colitis and FIN-525 for Crohn’s disease, two pre-clinical microbiome product candidates. FIN-524 and FIN-525 are designed to deliver bacterial strains selected for their potential to engage multiple pathways relevant to ulcerative colitis and Crohn’s disease, respectively. Finch is exploring opportunities to potentially advance the development of its candidates for IBD through strategic partnerships.