Pipeline

a diverse and
growing pipeline
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. Our diverse and growing pipeline includes product candidates targeting gastrointestinal diseases, such as recurrent C. difficile infection and inflammatory bowel disease, as well as product candidates aimed at conditions that go beyond the gut, such as autism spectrum disorder and chronic hepatitis B.

Program Indication Complete
Consortia
Targeted
Consortia
Enriched
Consortia
Preclinical Phase 1 Phase 2 Phase 3 Program
Rights
Gastronintestinal / Immunology CP101 Recurrent C. difficile
First pivotal completed
FIN-524 Ulcerative Colitis
FIN-525 Crohn’s Disease
Neuro FIN-211 Autism Spectrum Disorder
Liver CP101 Chronic Hepatitis B

CP101 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

CP101 for Recurrent CDI

  • 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 with positive data from its first pivotal trial demonstrating clinical efficacy in all stages of recurrent CDI, including first recurrence
  • Awarded Fast Track and Breakthrough Therapy designations by the FDA for the prevention of recurrent CDI

FIN-211 for autism spectrum disorder (ASD)

FIN-211 is an orally administered, Enriched Consortia product candidate designed to address both the gastrointestinal (GI) and behavioral symptoms of 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, with the most common GI symptom being constipation.

The Unmet Need

  • 1:54 children affected by ASD in the US (4.6 million individuals in the US)
  • >30% of individuals with ASD suffer from GI symptoms
  • >$100 billion spent on care for individuals with ASD in the US each year
  • Zero FDA-approved therapies for the core symptoms of ASD, as well as a lack of effective treatments for GI symptoms

FIN-211 for ASD

  • Oral delivery of a complete microbiome community that is enriched with a targeted microbe
  • Designed to address GI and behavioral symptoms by targeting multiple ASD-relevant pathways
  • Development program builds off mechanistic data and four investigator-sponsored, open label, proof-of-concept clinical studies showing improvement in both GI and behavioral symptoms following microbiota transplantation

CP101 for chronic hepatitis B (HBV)

CP101, an orally administered, Complete Consortia product candidate in late-stage clinical development for the prevention of recurrent C. difficile infection is also being developed for the treatment of chronic HBV.

Chronic HBV infection occurs when the initial immune response fails to clear the virus, and may result in inflammation of hepatocytes, and complications including cirrhosis, liver failure requiring liver transplantation, liver cancer, and death.

The Unmet Need

  • >290 million people globally have chronic HBV, with approximately 30 million individuals becoming newly infected every year
  • 900,000 deaths globally from chronic HBV-related complications per year
  • Currently available treatment options are poorly tolerated and ineffective for many chronic HBV patients, with active replication and elevated viral loads persisting after treatment
  • There is a need for safe and effective therapies that drive toward a functional cure for the millions of people suffering from chronic HBV

CP101 for Chronic HBV

  • Oral delivery of a lyophilized, intact microbiome community harvested from rigorously screened healthy, human donors
  • Designed to facilitate viral clearance by delivering an intact microbiome community that stimulates the immune system
  • Development program leverages mechanistic data and several investigator-sponsored, proof-of-concept clinical studies showing viral antigen clearance following microbiota transplantation

FIN-524 & FIN-525 for inflammatory bowel disease (IBD)

In collaboration with Takeda Pharmaceuticals, we are developing FIN-524 and FIN-525, orally administered, Targeted Consortia product candidates designed for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD), respectively.

UC and CD are the two most common types of IBD, an autoimmune condition that causes inflammation of the gastrointestinal (GI) tract.

The Unmet Need

  • 3 million individuals in the US and 10 million individuals worldwide affected by IBD
  • Symptoms of IBD include severe, chronic abdominal pain, diarrhea, GI bleeding, weight loss, and fatigue
  • Today’s treatment options do not address the underlying causes of the disease and are ineffective for many individuals with IBD

FIN-524 & FIN-525 for IBD

  • Oral delivery of select bacterial strains grown in pure culture
  • Bacterial strain selection driven by data from human microbiota transplantation studies and mechanistic data
  • Strains target multiple potentially disease-modifying mechanisms
  • Being developed in partnership with Takeda, a global leader in GI disease