Synthetic Biologics Says First Analysis Shows SYN-004 Protects Microbiome from IV Antibiotics Damage in Humanized Pig Model

Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, presented data from its novel SYN-004 program that demonstrated SYN-004 protected the gut microbiome from damage often caused by the intravenous (IV) beta-lactam antibiotic, ceftriaxone, in a pilot study of humanized pigs. The data were presented yesterday in a late-breaker oral presentation at the 2015 Interscience Conference of Antimicrobial Agents and Chemotherapy and International Congress of Chemotherapy and Infection joint meeting (ICAAC/ICC 2015) in San Diego, CA. SYN-004 is the Company's candidate therapy, currently in Phase 2 clinical trials, that is designed to degrade certain IV beta-lactam antibiotics within the gastrointestinal (GI) tract and maintain the natural balance of the gut microbiome for the prevention of C. difficile infection, antibiotic-associated diarrhea (AAD) and secondary antibiotic-resistant infections. C. difficile is frequently associated with IV antibiotic treatment and is the leading type of hospital acquired infection accounting for more than 1.1 million infectionsi and 30,000 related deathsii each year in the United States. Beta-lactam antibiotics are a mainstay of hospital infection management and include commonly used penicillin and cephalosporin antibiotics such as ceftriaxone. However, antibiotics may unintentionally disrupt the natural balance of the gut microbiome, potentially leading to the development of C. difficile infection. The Company's presentation, delivered by Vice President, Research, Sheila Connelly, Ph.D., summarized the microbiome analyses from the pilot study in which the pigs' colons were populated with human stool, as follows: Of significant importance, in the cohort that was administered oral SYN-004 plus IV ceftriaxone, the natural balance of bacteria in the gut microbiome was maintained. In contrast, in the cohort administered IV ceftriaxone alone, damage occurred and the natural balance of the gut microbiome was altered. "Showcasing positive data from our lead microbiome program this year at ICAAC/ICC is further encouragement that SYN-004 has the potential to become the first prophylactic therapy designed to protect the gut microbiome from the unintended damage caused by IV antibiotics, including C. difficile infection and antibiotic-associated diarrhea," stated Jeff Riley, Chief Executive Officer of Synthetic Biologics. "We continue to move SYN-004 through the clinical pathway and look forward to initiating our SYN-004 Phase 2b proof-of-concept trial expected later this quarter."