ROCKVILLE, Md., Sept. 28, 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, reported the initiation of its SYN-004 Phase 2b proof-of-concept clinical trial. The clinical trial is intended to evaluate the effectiveness of SYN-004 to prevent C. difficile infection (CDI), C. difficile associated diarrhea (CDAD) and antibiotic-associated diarrhea (AAD) in patients hospitalized for a lower respiratory tract infection and receiving intravenous (IV) ceftriaxone.
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 harmful effects within the gastrointestinal (GI) tract including disruption of the natural balance of the gut microbiome, leading to 1.1 million CDIsi and 30,000 C. difficile-related deathsii in the United States each year.
SYN-004 is Synthetic Biologics' oral prophylactic therapy designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of CDI, AAD and emergence of antibiotic-resistant organisms. To view the SYN-004 mechanism of action video on Synthetic Biologics' website, please click here.
"Initiating the SYN-004 Phase 2b clinical trial is an important milestone for Synthetic Biologics as it is intended to assess the proof-of-concept of SYN-004, which is designed to protect the microbiome and prevent CDIs and AAD," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "Several Phase 2b clinical sites are open for enrollment and actively screening for patients with additional sites expected to open as we approach the cold and flu season."
Mr. Riley added, "Before initiating the SYN-004 Phase 2b clinical trial, safety and tolerability was demonstrated in two Phase 1 studies: a single-ascending dose study and a multiple-ascending dose study. Full analysis was completed and study reports were submitted to the FDA.
"In addition, our novel Phase 2a clinical trials are evaluating the GI antibiotic-degrading effects and the safety of SYN-004, both alone and in the presence of the proton pump inhibitor (PPI), esomeprazole, in participants with ileostomies (colon and rectum removed, or just part of small intestine removed). They are intended to generate additional pharmacokinetics (PK) and pharmacodynamics (PD) data to support SYN-004, and in the case of the PPI study, to analyze any potential drug-drug interactions.
"We have now enrolled enough participants to complete the first Phase 2a trial analysis, even though the recruitment of qualified ileostomized participants was slower than anticipated. We are very grateful to these at-risk participants for being a part of these studies and helping us further the development of SYN-004 for the prevention of CDIs and AAD. The Phase 2a studies are ongoing and we will report topline data from each of them when full data analysis is available. We anticipate results will be consistent with our expectations and the positive PK and safety results demonstrated in the SYN-004 Phase 1a and 1b studies previously reported in March 2015, and in the first four participants in the first Phase 2a previously reported in July 2015."
SYN-004 Phase 2b Proof-of-Concept Clinical Trial Design
The Phase 2b, parallel-group, double-blind, placebo-controlled study of SYN-004 is expected to enroll approximately 370 patients at up to 75 global clinical sites. Patients age 50 years and older, hospitalized for a lower respiratory tract infection, are expected to be randomized 1:1 into two groups, and receive either SYN-004 or placebo during the standard of care regimen of ceftriaxone (with or without a macrolide). The primary objectives of this clinical trial are to evaluate the effectiveness of SYN-004 to prevent CDIs and CDAD. The secondary objective of this clinical trial is to evaluate the effectiveness of SYN-004 to prevent AAD.
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 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 to 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 and antibiotic-associated diarrhea, the intent of the Phase 2b proof-of-concept clinical trial, the potential market size, the expected enrollment and opening of additional sites, and the anticipated results from the Phase 2a clinical trials. 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.
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SOURCE Synthetic Biologics, Inc.