Product Pipeline

Overview

Synthetic Biologics, Inc. (NYSE American: SYN) is a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need. The Company’s lead candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent (a) microbiome damage, (b) Clostridioides difficile infection (CDI), (c) overgrowth of pathogenic organisms, (d) the emergence of antimicrobial resistance (AMR) and (e) acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases.

Microbiome & GI-focused Pipeline

Candidate & Indication Development Stage
Preclinical Phase 1 Phase 2 Phase 3 Market
SYN-004 (ribaxamase) Prevention of CDI, pathogenic overgrowth, AMR and aGVHD in allogeneic HCT recipients
SYN-004 (ribaxamase) Prevention of CDI, pathogenic overgrowth, AMR and aGVHD in allogeneic HCT recipients
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase not started
Market Phase not started
SYN-020 Prevention of enteropathy secondary to radiation therapy for pelvic cancers
SYN-020 Prevention of enteropathy secondary to radiation therapy for pelvic cancers
Preclinical Phase complete
Phase 1 Phase not started
Phase 2 Phase not started
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 infection while protecting the gut microbiome from dysbiosis and thus preventing Clostridioides difficile infection (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients.

View SYN-004 (ribaxamase)

SYN-020

SYN-020 is a recombinant version of bovine Intestinal Alkaline Phosphatase (IAP) produced under cGMP conditions and formulated for oral delivery. The diverse mechanisms of IAP action indicate that SYN-020 may have utility in a broad range of therapeutic indications, including radiation enteropathy associated with the treatment of pelvic cancers, and indications related to the use of IAP to maintain GI and microbiome health, diminish systemic inflammation, and treat age-related diseases.

View SYN-020

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-005 Pertussis (Whooping Cough)
SYN-005 Pertussis (Whooping Cough)
Discovery Phase complete
Preclinical Phase in progress

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-005

We are developing SYN-005, a combination of two humanized antibodies that includes hu1B7, for the treatment of critically ill infants with Pertussis, in collaboration with academic researchers at the University of Texas Austin (UT Austin). 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.