Synthetic Biologics’ Reports Preclinical Data to Support Clinical Development of Novel Pertussis Therapeutic

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April 23, 2014

Synthetic Biologics, Inc., a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, announced positive preclinical research findings for SYN-005, the Company’s proprietary monoclonal antibody (mAb) combination therapy for treating Pertussis (whooping cough), in two non-human primate studies (n=15). In the second pertussis study in particular, SYN-005 was associated with favorable decreases in white blood cell counts within two days and the achievement of nearly normal levels within one week. Based on positive non-human primate and murine model findings, Synthetic Biologics has filed an additional patent application around pertussis antibodies, intends to move into cGMP manufacturing of SYN-005, and intends to file an Investigational New Drug (IND) application to support a Phase I clinical trial expected to initiate during the first half of 2015. The Company also intends to request an Orphan Drug designation for SYN-005 for the treatment of Pertussis.

Synthetic Biologics is developing SYN-005 through its Exclusive Channel Collaboration with Intrexon Corporation and academic researchers at The University of Texas at Austin to target and neutralize the pertussis toxin in order to reduce morbidity and mortality in infected infants. Pertussis is a highly contagious disease caused by the bacteria Bordetella pertussis (B. pertussis) with symptoms that may include chronic coughing and subsequent breathing difficulties.

Despite widespread vaccination since the 1940s, Pertussis rates in the United States have been rising steadily due to a less effective vaccine introduced in the 1990s, exposure of unvaccinated and under-vaccinated individuals including infants, exposure of individuals whose immunity has diminished over time, and an increased prevalence of asymptomatic carriers. According to the World Health Organization, B. pertussisinfection causes an estimated 300,000 deaths worldwide each year, primarily among young, unvaccinated infants.

Antibiotic use does not have a major effect on the course of Pertussis because, while it can eliminate the B. pertussis bacteria from the respiratory tract, it does not neutralize the pertussis toxin. Attacking the pertussis toxin in infants is an urgent unmet medical need. This secreted toxin is a major cause of disease virulence as it paralyzes the immune system, causes the white blood cell count to increase, sometimes to levels that block blood flow through the lungs, and predisposes the infant to severe pneumonia.

“There is a critical need to address the re-emergence of Pertussis as a rising public health concern. The growing body of evidence for SYN-005 provides strong support for its clinical development as potentially a new treatment approach and the only one designed to neutralize the pertussis toxin itself,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. We believe this novel intervention has the potential to mitigate the course of the illness, which, in human infants, could potentially be life-saving.”

“Results from these promising initial studies suggest SYN-005 could be effective against Pertussis in the acute setting,” said Gregory Frost, Ph.D., Senior Vice President of Intrexon’s Health Sector. “This toxin-neutralizing antibody approach for infectious disease is biologically rational, and if replicated clinically, could represent a novel paradigm in the treatment of this serious unmet medical need.”

SYN-005 Candidate for the Treatment of Pertussis

SYN-005 combines two highly synergistic humanized mAbs to target and potentially inactivate the life-threatening pertussis toxin. In IND-enabling studies, SYN-005 was associated with significant reductions in white blood cell count and bacterial loads in non-human primate and murine animal models. Synthetic Biologics further strengthened its intellectual property position around pertussis antibodies with an additional patent filing. The Company is initiating manufacturing for non-clinical and clinical studies, and intends to request an Orphan Drug designation for SYN-005 for the treatment of Pertussis.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology company focused on the development of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and  diseases. The Company is developing an oral treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS), an oral biologic to protect the gastrointestinal microflora from the effects of IV antibiotics for the prevention of Clostridium difficile (C. difficile) infection, a series of monoclonal antibodies for the treatment of Pertussis and Acinetobacter infections, and a biologic targeted at the prevention and treatment of a root cause of a subset of IBS. In addition, the Company is developing an oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

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