Synthetic Biologics Reports First Analysis Demonstrating SYN-004’s Ability to Protect the Microbiome from Damage Caused by IV Antibiotics in a Humanized Pig Model

— Late-Breaker Oral Presentation at ICAAC/ICC 2015 Highlights Data from Novel Gut Microbiome Program —

ROCKVILLE, Md., Sept. 21, 2015 /PRNewswire/ — 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.

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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.”

About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a microbiome-focused, clinical-stage company developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company’s lead candidates in Phase 2 development include SYN-004 which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD), and SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat the underlying cause of irritable bowel syndrome with constipation (IBS-C). In addition, the Company is developing a Phase 2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, and in collaboration with Intrexon Corporation (NYSE: XON), a monoclonal antibody combination for the treatment of Pertussis and biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics’ website at

This release includes forward-looking statements on Synthetic Biologics’ current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the design of SYN-004, the potential for SYN-004 to become the first prophylactic therapy designed to protect the gut microbiome from the unintended damage caused by IV antibiotics, the continued clinical pathway for SYN-004 and the timing of the Phase 2b proof-of-concept clinical trial. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics’ forward-looking statements include, among others, the additional clinical studies and results not meeting expectations, the inability to commence and complete clinical trials when expected and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2014 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

i This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

ii U.S. Department of Health & Human Services. Agency for Healthcare Research and Quality. January 25, 2012. Accessed: June 7. 2015.

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SOURCE Synthetic Biologics, Inc.