ROCKVILLE, Md., June 12, 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, dosed the first participant in a second Phase 2a clinical trial of SYN-004. This trial will evaluate the gastrointestinal (GI) antibiotic-degrading effects and the safety of SYN-004, in the presence of the proton pump inhibitor (PPI), esomeprazole. 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.
C. difficile is the leading type of hospital acquired infection and is frequently associated with IV antibiotic treatment. Beta-lactam antibiotics are a mainstay in hospital infection management, and include commonly used penicillin and cephalosporin antibiotics, such as ceftriaxone. However, antibiotics have the potential to cause unintended harmful effects within the GI tract, including disruption of the natural balance of the gut microbiome, leading to 1.1 million C. difficile infections[i] and 30,000 C. difficile-related deaths[ii] in the United States each year.
PPIs are often used prophylactically in hospitalized patients. Therefore, with guidance from the U.S. Food and Drug Administration (FDA), Synthetic Biologics is conducting this study to demonstrate the ability of SYN-004 to degrade an intravenous (IV) antibiotic in the presence of a PPI.
"As participants complete the first Phase 2a clinical trial of SYN-004, they have the option to continue the evaluation of SYN-004 by moving into this second Phase 2a clinical trial," stated Joseph Sliman, M.D., M.P.H., Senior Vice President, Clinical & Regulatory Affairs of Synthetic Biologics. "Collecting data in this second Phase 2a trial allows us to build a pharmacokinetics (PK) model, a valuable tool when other antibiotics are evaluated in the future. We want to clearly demonstrate the ability of SYN-004 to degrade antibiotics in the gut, to protect the microbiome from the damaging effects of antibiotics and dramatically reduce C. difficile infections through prevention vs. treatment. We remain on track to complete and report preliminary data from the first Phase 2a clinical trial within the month, and to initiate the Phase 2b clinical trial in the third quarter of this year."
This second Phase 2a multi-center, open-label, 2-period, fixed-sequence study is expected to evaluate the ability of SYN-004 to degrade residual IV ceftriaxone in the GI tract in the presence of a PPI in up to 20 healthy participants with functioning ileostomies. The study consists of two treatment periods for all participants: 1) the administration of SYN-004 and IV ceftriaxone, and 2) the administration of SYN-004 and IV ceftriaxone in the presence of esomeprazole, an approved, over-the-counter PPI. Chyme samples will be collected from the participants to measure the ability of SYN-004 to degrade the residual antibiotic. Participants are expected to be enrolled at up to four trial sites located in the United States and Canada.
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 (Phase 2a) 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 potential of SYN-004 degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of C. difficile infection, the anticipated timing of the reporting of preliminary data from the Phase 2a clinical trial and the timing of initiation of the Phase 2b clinical trial and the potential market for SYN-004. 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, a failure to receive the necessary regulatory approvals for commercialization of Synthetic Biologics' therapeutics, a failure of Synthetic Biologics' clinical trials, and those conducted by investigators, to be commenced or completed on time or to achieve desired results, a failure of Synthetic Biologics' clinical trials to receive anticipated funding, a failure of Synthetic Biologics' products for the prevention and treatment of diseases to be successfully developed or commercialized, Synthetic Biologics' inability to maintain its licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products 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: June 7. 2015.
SOURCE Synthetic Biologics, Inc.