Product Pipeline

Overview

Our two lead candidates focused on protection and preservation of the gut microbiome are: ribaxamase, designed to prevent primary C. difficile infection (CDI) and pathogenic overgrowth and the emergence of antimicrobial resistance (AMR) and SYN-010, designed to reduce methane production in the GI to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C).

Our research candidates include monoclonal antibody therapies for the prevention and treatment of Pertussis and novel biotherapeutics for the treatment of patients with 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
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
Market Phase not started
SYN-010 Treatment of IBS-C
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
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-005 Pertussis (Whooping Cough)
Discovery Phase complete
Preclinical Phase in progress
SYN-200 Phenylketonuria (PKU)
Discovery Phase in progress
Preclinical Phase not started

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.