Synthetic Biologics Presents Initial Data Validating Platform Expansion to Cover Carbapenem Antibiotics

— Successful Clinical Development Would Enable Company’s Microbiome-Protecting Therapeutics to Cover all Three Beta-Lactam Antibiotic Classes —

— Webcast Details Below for Microbiome Analyst & Investor Meeting Live Today at 9:00 a.m. EDT —

ROCKVILLE, Md., June 3, 2015 /PRNewswire/ — Synthetic Biologics, Inc. (NYSE MKT: SYN), this week presented initial data that support the Company’s development of a platform of therapeutics designed to protect the microbiome from carbapenems, a class of beta-lactam antibiotics. The data were presented in a poster at the 115th General Meeting of the American Society of Microbiology (ASM) in New Orleans, LA.

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Beta-lactam antibiotics are a mainstay in hospital infection management. However, antibiotics have the potential to cause unintended harmful effects within the gastrointestinal (GI) tract, including disruption of the natural balance of the gut microbiome, leading to 1.1 million C. difficile infectionsi and 30,000 C. difficile-related deathsii in the United States each year. SYN-004 is the Company’s candidate therapy designed to degrade certain intravenous (IV) beta-lactam antibiotics within the 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. SYN-004 is designed to protect the microbiome from two classes of beta-lactam antibiotics, penicillins and cephalosporins.

During ASM, the “Development of Therapeutic Agents that Protect the Colonic Microflora from Beta-Lactam Antibiotics for the Prevention of Clostridium difficile Infection” poster summarized the identification of a novel pipeline beta-lactamase, P2A, which has the ability to protect the gut microbiome from a third class of beta-lactam antibiotics, carbapenems. Adding P2A to the franchise platform expands Synthetic Biologics’ intellectual property claims to cover all three beta-lactam antibiotic classes, penicillins, cephalosporins, and carbapenems.

“We continue to build our intellectual property portfolio in order to cover expansion of the beta-lactamase platform that focuses on protecting the gut microbiome for the prevention of C. difficile infection and antibiotic-associated diarrhea,” stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “As a result of these data we are now exploring the potential of our platform to protect the microbiome against carbapenems, the third class of beta-lactam antibiotics. Successful clinical development could maximize clinician acceptance of our product line upon commercialization. At the same time, we continue to enroll participants into a Phase 2a clinical trial of SYN-004, and we are on track to initiate a proof-of-concept Phase 2b clinical trial of SYN-004 during the third quarter of 2015.”

Second Poster Presented at ASM

Synthetic Biologics also presented a poster titled “Clinical Evaluation of SYN-004, an Oral Beta-Lactamase Therapy for the Prevention of Antibiotic-Induced Disruption of Intestinal Microflora” which summarized Phase 1 clinical data supporting the SYN-004 program. The following conclusions were presented from the Phase 1a (40 participants) and Phase 1b (24 participants) clinical trials of SYN-004:

  • SYN-004 was safe and well tolerated at a single dose of up to 750mg and at multiple doses of 300mg four times a day for seven days
  • There were no identified safety or tolerability concerns attributable to SYN-004; and
  • No meaningful levels of SYN-004 were observed in the bloodstream at the clinical doses evaluated

Webcast of Synthetic Biologics’ Microbiome Analyst & Investor Meeting

A live webcast of the presentations will begin today, June 3, 2015, at 9:00 a.m. EDT and the webcast is scheduled to conclude by 11:30 a.m. EDT. The live webcast of the event will be available via the internet at: https://tallen.webcasts.com/starthere.jsp?ei=1066312. An archived webcast will be available at the same website following the meeting.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company is developing an oral biologic to protect the gut microbiome from intravenous (IV) antibiotics for the prevention of C. difficile infection and an oral statin treatment to reduce the impact of methane producing organisms on irritable bowel syndrome with constipation (IBS-C). In addition, the Company is developing a monoclonal antibody combination for the treatment of Pertussis in collaboration with Intrexon Corporation (NYSE: XON), and a Phase 2 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.

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 intended treatment for SYN-004 and its designed protection of the microbiome against certain beta-lactam antibiotics, including carbapenems, continued enrollment of the Phase 2a clinical trial, anticipated timing of the initiation of the Phase 2b clinical trial, continued expansion of the intellectual property portfolio and the size of the market. 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 ability of the clinical trials to be performed when anticipated, the ability of SYN-004 to perform as expected, the results of the clinical trials 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. http://www.ahrq.gov/news/nn/nn012512.htm Accessed: September 30, 2013.

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SOURCE Synthetic Biologics, Inc.