Product Pipeline

Overview

Our two lead candidates poised for Phase 3 development are: (1) SYN-004 (ribaxamase) which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection (CDI), overgrowth of pathogenic organisms and the emergence of antimicrobial resistance (AMR), and (2) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C).

Our preclinical pursuits include an oral formulation of the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases as well as monoclonal antibody therapies for the prevention and treatment of pertussis, and novel discovery stage biotherapeutics for the treatment of phenylketonuria (PKU).

Microbiome-Focused Pipeline

Candidate & Indication Development Stage
Preclinical Phase 1 Phase 2 Phase 3 Market
SYN-004 (ribaxamase) Prevention of CDI, pathogenic overgrowth and AMR
SYN-004 (ribaxamase) Prevention of CDI, pathogenic overgrowth and AMR
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase not started
Market Phase not started
SYN-010 Treatment of IBS-C
SYN-010 Treatment of IBS-C
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase not started
Market Phase not started

SYN-004 (ribaxamase)

Designed to be co-administered with IV beta-lactam antibiotics, ribaxamase is an oral enzyme tablet that allows the IV antibiotic to treat the infection, while protecting the gut microbiome and preventing Clostridium difficile infection (CDI), pathogenic overgrowth and the emergence of antimicrobial resistance (AMR). SYN-004 received Breakthrough Therapy Designation from the FDA for the prevention of Clostridium difficile Infection.

View SYN-004 (ribaxamase)

SYN-010

SYN-010 is a proprietary, modified-release formulation of lovastatin lactone that is designed to bypass the stomach and reduce the body’s natural methane production in the GI tract to treat an underlying cause of the symptoms associated with irritable bowel syndrome with constipation (IBS-C).

View SYN-010

Research Pipeline

Candidate & Indication Research Stage
Discovery Preclinical
SYN-006
SYN-006
Discovery Phase complete
Preclinical Phase in progress
SYN-007
SYN-007
Discovery Phase complete
Preclinical Phase in progress
SYN-020
SYN-020
Discovery Phase in progress
Preclinical Phase not started
SYN-005 Pertussis (Whooping Cough)
SYN-005 Pertussis (Whooping Cough)
Discovery Phase complete
Preclinical Phase in progress
SYN-200 Phenylketonuria (PKU)
SYN-200 Phenylketonuria (PKU)
Discovery Phase in progress
Preclinical Phase not started

SYN-006

SYN-006 is a carbapenemase designed to degrade intravenous (IV) carbapenem antibiotics within the gastrointestinal (GI) tract to maintain the natural balance of the gut microbiome for the prevention of CDI, overgrowth of pathogenic organisms and the emergence of antimicrobial resistance (AMR). Carbapenems are broad-spectrum beta-lactam antibiotics that have been shown to significantly damage the gut microbiome, incur a high risk for C. difficile infection, and enable GI overgrowth with multidrug resistant organisms. We have successfully formulated SYN-006 for oral delivery and evaluated it in a porcine efficacy model in conjunction with IV ertapenem.

SYN-007

SYN-007 is a specially formulated version of SYN-004 (ribaxamase) designed to degrade orally administered beta-lactam antibiotics to protect the gut microbiome from antibiotic-mediated dysbiosis. SYN-007 extends gut microbiome protection from antibiotic-mediated dysbiosis by continuing protection after patients have been transferred from an intravenous (IV) beta-lactam antibiotic to an oral beta-lactam antibiotic. Data from a recent canine study completed during the second half of 2017 demonstrated that, when co-administered with oral amoxicillin, SYN-007 did not interfere with amoxicillin absorption and demonstrated protection of the gut microbiome.

SYN-020

SYN-020 is being developed as a modified-release oral dosage form of intestinal alkaline phosphatase (IAP). IAP is an endogenous enzyme expressed in the upper gastrointestinal (GI) tract that functions as a broadly acting phosphatase that serves to maintain homeostasis and promote commensal microbiota. Published reports have demonstrated efficacy for several indications with oral IAP in animal models including colitis, antibiotic-mediated dysbiosis, and metabolic syndrome as well as a pilot human clinical trial with ulcerative colitis patients. In 2017, we generated high expressing manufacturing cell lines for IAP and identified downstream process and potential tablet formulation. We are currently optimizing these technologies and pursuing animal efficacy studies to identify potential future clinical indications.

Collaborative Partners


SYN-005

Through our August 2012 Exclusive Channel Collaboration (ECC) with Intrexon Corporation (NYSE: XON) and academic researchers at The University of Texas at Austin (UT Austin), we are developing SYN-005, a combination of two humanized antibodies that includes hu1B7, for the treatment of critically ill infants with Pertussis. In addition, UT Austin was awarded a grant from the Gates Foundation to generate preclinical proof-of-concept data to test the hypothesis that hu1B7 antibody administration at birth may also have a role in the prevention of Pertussis. Jennifer Maynard, Ph.D., the principal investigator of the grant at UT Austin, will test this hypothesis by using our hu1B7 antibody.

SYN-200

Through our August 2015 ECC with Intrexon Corporation, we are pursuing the development and commercialization of novel biotherapeutics for the treatment of patients with phenylketonuria (PKU), a serious and debilitating metabolic disorder. Through the ECC, we plan to utilize Intrexon's ActoBiotics™ platform which is a proprietary method of delivering therapeutic protein and peptides to the gastrointestinal (GI) tract through food-grade microbes.