Product Pipeline

Overview

Synthetic Biologics, Inc. is a clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need. Our lead clinical 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 microbiome damage, C. 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, 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). The Company is also advancing SYN-020, an oral formulation of the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases.

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 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 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-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 Treatment of enteropathy secondary to radiation therapy for pelvic cancers
SYN-020 Treatment of enteropathy secondary to radiation therapy for pelvic cancers
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-020

SYN-020 is a purified recombinant bovine intestinal alkaline phosphatase (IAP) formulated for oral delivery to the intestines. A growing body of research indicates that IAP functions to tighten the gut barrier to diminish “leaky gut,” promote a healthy microbiome and diminish both intestinal and systemic inflammation. Synthetic Biologics is currently developing SYN-020 to reduce acute intestinal side effects associated with radiation therapy in patients with pelvic cancers. An Investigational New Drug (IND) application supporting advancement of this program into clinical trials has been filed with the FDA.

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.