Platform
The microbiome:
Essential for health.
Harnessed for medicine.
The microbiome consists of trillions of microbes that live symbiotically in and on every human and are essential to our health. When key microbes are lost, the resulting dysbiosis (microbiome disruption) can increase susceptibility to immune disorders, infections, neurological conditions, cancer, and other serious conditions. We are leveraging our Human-First Discovery® platform to develop novel therapeutics designed to deliver missing microbes and their clinically relevant biochemical functions to correct dysbiosis and the conditions that emerge from it.
Our Human-First Discovery platform & product strategies
Our platform is fueled by data from human microbiota transplantation studies. These studies involve the transfer of microbiota from healthy individuals to individuals with disease, an area of intense research with hundreds of studies spanning dozens of different conditions. We leverage data from these types of studies, plus machine learning and molecular characterization techniques, to identify conditions where a disrupted microbiome is driving disease and to uncover the key dynamics associated with successful clinical outcomes.
Our platform enables the development of product candidates that deliver complete microbiome communities to restore broad community function and candidates that contain select microbes targeting specific biological pathways. This combination of capabilities uniquely positions us to develop three different types of candidates designed to address different types of dysbiosis that lead to microbiome-mediated conditions.
Complete Consortia
Delivers complete microbial community to restore broad community function
Enriched Consortia
Hybrid approach to restore broad community function and target specific pathways
Targeted Consortia
Delivers selected microbes to target specific biological pathways
Our Human-First Discovery platform enables:
The design of our product candidates is driven by reverse translation from successful human microbiota transplantation studies, avoiding the translational risk associated with approaches that rely upon in vitro or animal models of disease to drive candidate selection.
We believe we can rapidly enter the clinic with CP101, our Complete Consortia product candidate, allowing us to evaluate the use of a microbiome therapeutic for the treatment of conditions that already have shown promising proof-of-concept data. Our plans for accelerated development of CP101 have the potential to allow us to develop therapeutics intended to address unmet needs quickly, while simultaneously generating robust datasets that can be leveraged to fuel the development of second-generation therapeutics.
Microbiome drugs have the potential to be disease-modifying agents, addressing the underlying cause of a condition rather than just treating the symptoms. For example, in recurrent C. difficile infection, microbiome therapeutics address the root cause of recurrence by restoring the diversity of the microbiome and colonization resistance.
An industry leading IP portfolio
Our platform is supported by a large and diverse patent portfolio that consists of more than 50 issued U.S. and foreign patents, as well as more than 130 patent applications, that embodies pioneering work in the microbiome field.
Supporting literature
Duodenal Infusion of Donor Feces for Recurrent Clostridium Difficile The New England Journal of Medicine
CP101 Publications and Conference Abstracts:
Successful Resolution of Recurrent Clostridium difficile Infection using Freeze-Dried, Encapsulated Fecal Microbiota; Pragmatic Cohort Study The American Journal of Gastroenterology
An Investigational Oral Microbiome Drug, CP101, for the Prevention of Recurrent C. difficile Infection: A Randomized, Placebo-Controlled, Multi-Center Trial (PRISM3) – Late Breaking Abstract #LB21 United European Gastroenterology Journal
Long-Term Benefit of Microbiota Transfer Therapy on Autism Symptoms and Gut Microbiota Scientific Reports
Combined Oral Fecal Capsules Plus Fecal Enema as Treatment of Late-Onset Autism Spectrum Disorder in Children: Report of a Small Case Series Open Forum Infectious Diseases
Fecal Microbiota Transplantation for Children with Autism Spectrum DisorderGastrointestinal Endoscopy
Short-Term Benefit from Oral Vancomycin Treatment of Regressive-Onset Autism Journal of Child Neurology
IL-17a Promotes Sociability in Mouse Models of Neurodevelopmental Disorders Nature
Fecal Microbiota Transplantation in Hepatitis B e Antigen-Positive Chronic Hepatitis B Patients: A Pilot Study Digestive Diseases and Sciences
Age-Related Immune Clearance of Hepatitis B Virus Infection Requires the Establishment of Gut Microbiota Proceedings of the National Academy of Sciences of the United States of America
CD4+ T Cells Play a Critical Role in Microbiota-Maintained Anti-HBV Immunity in a Mouse Model Frontiers in Immunology
Single Delivery of High-Diversity Fecal Microbiota Preparation by Colonoscopy Is Safe and Effective in Increasing Microbial Diversity in Active Ulcerative Colitis Inflammatory Bowel Diseases
Fecal Microbiota Transplantation Induces Remission in Patients with Active Ulcerative Colitis in a Randomized Controlled Trial Gastroenterology
Systematic Review and Meta-analysis: Fecal Microbiota Transplantation for Treatment of Active Ulcerative Colitis Inflammatory Bowel Diseases
Faecal Microbiota Transplantation for Inflammatory Bowel Disease: A Systematic Review and Meta-analysis Journal of Crohn’s and Colitis