Synthetic Biologics Announces Completion of Enrollment for Phase 2b Proof-of-Concept Clinical Trial for SYN-004 (ribaxamase) for the Prevention of Clostridium Difficile Infection, Antibiotic-Associated Diarrhea and the Emergence of Antibiotic-Resistant Organisms
-- Top-line Results Anticipated in the First Quarter of 2017 --
ROCKVILLE, Md., Sept. 20, 2016 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused on developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases, announced today that following the completion of a previously planned interim analysis by an independent Interim Analysis Committee (IAC), enrollment has been completed in its Phase 2b randomized, placebo-controlled, proof-of-concept clinical trial for SYN-004 (ribaxamase).
Following a closed session with the IAC in which the Company remained blinded to the study data, a recommendation was given to continue the study per protocol without modification and no safety issues were identified. Successful enrollment of 413 patients has occurred exceeding the desired sample size of 372 patients outlined per the study protocol. All ongoing patients are expected to continue through the follow-up period in order to complete the study. The Company anticipates announcing top-line results during the first quarter of 2017.
"The completion of enrollment in our Phase 2b proof-of-concept study for ribaxamase represents a critical milestone for the company and one that exhibits our continued focus of moving our innovative approach to preventing CDI, AAD and antibiotic resistance into late-stage clinical development," said Jeffrey Riley, President and Chief Executive Officer. "We would like to thank the patients and clinical sites that are participating in this study as well as our colleagues for their commitment and dedication to this important and potentially groundbreaking clinical trial. We look forward to announcing top-line results during the first quarter of 2017."
About SYN-004 (ribaxamase) and the Phase 2b Study
SYN-004 (ribaxamase) is a first-in-class oral enzyme 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 the emergence of antibiotic-resistant organisms. The Phase 2b proof-of-concept clinical trial is intended to evaluate the effectiveness of ribaxamase to prevent the onset of C. difficile infection (CDI), C. difficile associated diarrhea (CDAD), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms in patients hospitalized with a lower respiratory infection and receiving intravenous (IV) ceftriaxone. To access the ribaxamase mechanism of action video on Synthetic Biologics' website, please click here.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage company developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases. The Company's lead candidates poised for Phase 3 development are: (1) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C), and (2) SYN-004 (ribaxamase) which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection, antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms. The Company is also developing preclinical stage monoclonal antibody therapies for the prevention and treatment of pertussis and novel discovery stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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, and include statements regarding the expectation that all ongoing patients will continue through the follow-up period in order to complete the study, the anticipated announcement of top-line results during the first quarter of 2017, Synthetic Biologics' continued focus of moving its innovative approach to preventing CDI, AAD and antibiotic resistance into late-stage clinical development, the intended evaluation in the Phase 2b proof-of-concept clinical trial of the effectiveness of ribaxamase to prevent the onset of C. difficile infection (CDI), C. difficile associated diarrhea (CDAD) and antibiotic-associated diarrhea (AAD) in patients hospitalized with a lower respiratory infection and receiving intravenous (IV) ceftriaxone, the potentially groundbreaking nature of this trial and the intended results to be achieved by use of SYN-010 and SYN-004. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict and could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, Synthetic Biologics' product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, Synthetic Biologics' ability to initiate clinical trials and if initiated, to complete them on time and achieve desired results and benefits, Synthetic Biologics ability to successfully design a protocol and a corresponding statistical analysis plan to support the execution of the first pivotal clinical trial for SYN-010, Synthetic Biologics' clinical trials continuing enrollment as expected, Synthetic Biologics' ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Synthetic Biologics' ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of Synthetic Biologics' products by competitors that render Synthetic Biologics' products obsolete or non-competitive, Synthetic Biologics' ability to maintain its license agreements, the continued maintenance and growth of Synthetic Biologics' patent estate, Synthetic Biologics becoming and remaining profitable, Synthetic Biologics' ability to establish and maintain collaborations, Synthetic Biologics' ability to obtain or maintain the capital or grants necessary to fund its research and development activities, a loss of any of Synthetic Biologics' key scientists or management personnel, and other factors described in Synthetic Biologics' Annual Report on Form 10-K for the year ended December 31, 2015 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. 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.
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SOURCE Synthetic Biologics, Inc.
Released September 20, 2016