— Data Supporting Development of Expanded C. difficile Preventive Therapeutics also Accepted for Presentation —
ROCKVILLE, Md., April 1, 2015 /PRNewswire/ — Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that clinical data supporting the development of SYN-004, the Company’s candidate therapy designed to degrade certain beta-lactam intravenous (IV) 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 and secondary antibiotic-resistant infections, has been selected for presentation during the 115th General Meeting of the American Society of Microbiology (ASM2015) in New Orleans, LA on May 30-June 1.
A second poster featuring Synthetic Biologics’ data will be presented at ASM2015. These data support expanding the development of therapeutics designed to protect the microbiome from all beta-lactam antibiotics for the prevention of C. difficile infection, beyond penicillins and cephalosporins. The schedule for the two poster presentations will be as follows:
Title: Clinical Evaluation of SYN-004, an Oral Beta-Lactamase Therapy for the Prevention of Antibiotic-Induced Disruption of Intestinal Microflora
Authors: J. Sliman, J. A. Bristol, S. Hubert, O. Coughlin, J. Kokai-Kun, A. Sloan, H. Whalen, T. Roberts, M. Schlosser, S. Connelly, P. Koski, M. Kaleko; Synthetic Biologics, Inc., Rockville, MD
Date/Time: Monday, June 1, 2015, 10:45am – 12:00pm (CT)
Poster Board Number: 953
Title: Development of Therapeutic Agents that Protect the Colonic Microflora from All Beta-Lactam Antibiotics for the Prevention of Clostridium difficile Infection
Authors: S. Connelly1, T. Parsley2, P. Koski1, M. Kaleko1; 1Synthetic Biologics, Inc., Rockville, MD, 2SynPhaGen, LLC, Rockville, MD
Date/Time: Tuesday, June 2, 2015, 12:30pm – 1:45pm (CT)
Poster Board Number: 2339
“Our microbiome-focused, C. difficile preventive therapy candidate, SYN-004, continues to gain recognition and attention as this clinical program moves into Phase 2 development,” stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “We initiated a Phase 2a clinical trial of SYN-004 in March, and anticipate initiating a Phase 2b clinical trial during the second half of this year.”
The U.S. Centers for Disease Control and Prevention (CDC) has categorized C. difficile as an “urgent public health threat,” and has stated the need for research to better understand the role of normal gut bacteria. SYN-004 is intended to block the unintended harmful effects of antibiotics within the GI tract and maintain the natural balance of the gut microbiome, potentially preventing the 1.1 million C. difficile infectionsi and 30,000 C. difficile-related deathsii in the United States each year. Approximately 118 million doses of IV beta-lactam antibioticsiii that could be inactivated in the GI tract by SYN-004, were administered to approximately 14 million hospitalized U.S. patients during 2012.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage biotechnology company developing pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome. The Company is developing an oral biologic to protect the gut microbiome from intravenous (IV) antibiotics for the prevention of C. difficile infection, an oral statin treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS), and in collaboration with Intrexon Corporation (NYSE: XON), a monoclonal antibody combination for the treatment of Pertussis. 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. For more information, please visit Synthetic Biologics’ website at www.therivabio.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, continued recognition and attention of SYN-004, anticipated timing of the initiation of the Phase 2b clinical trial 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 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.
iii 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.
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SOURCE Synthetic Biologics, Inc.
Released April 1, 2015