— Supportive Evidence for No Active Enzyme Absorption into Bloodstream Observed in Phase 1 Studies —
— Results Pave Way for Phase 2a Clinical Trial to Start this Month —
ROCKVILLE, Md., March 19, 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 positive pharmacokinetics (PK) results from both the Phase 1a and 1b studies of SYN-004, which is being developed to protect the microbiome and prevent Clostridium difficile (C. difficile) infection.
“The PK data confirmed that SYN-004 acts as Synthetic Biologics intended. SYN-004 goes directly to the gut where intravenous (IV) antibiotics are excreted, with the intention of protecting the microbiome from a cascading set of events that often lead to potentially deadly C. difficile infections,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “These data support our expectations that SYN-004 should have no effect on the IV antibiotic in the bloodstream, therefore allowing the antibiotic to do its job and fight the primary infection. We look forward to continuing the clinical evaluations of our lead candidate, SYN-004, with the initiation of a Phase 2a clinical trial this month.”
The Phase 1a, single-ascending dose PK study provided data to support Synthetic Biologics’ hypothesis that SYN-004 taken orally was not systemically available in the dose range tested. The PK data from this study measured blood levels of a single dose of SYN-004 in participants over a 10-fold dose range. Minimal levels of SYN-004 were observed in the bloodstream across the dose range investigated in the participants.
The Phase 1b, multiple-ascending dose PK study provided data to further support that SYN-004 is not systemically available, as no meaningful levels of SYN-004 were observed in the bloodstream after participants received multiple doses of SYN-004 four times a day over a seven-day period. The PK data confirm Synthetic Biologics’ expectations based on previous data from the first generation enzyme (P1A).
In addition, no clinically significant safety events were observed, and both the single and multiple doses of SYN-004 were well tolerated by the participants of the Phase 1 studies. Synthetic Biologics intends to continue the clinical development of SYN-004 in a Phase 2a clinical trial to evaluate the ability of SYN-004 to degrade residual IV antibiotic in the gastrointestinal (GI) tract, therefore potentially protecting the gut microbiome and preventing C. difficile infection.
Currently, there is no vaccine or drug approved by the U.S. Food and Drug Administration (FDA) specifically for the prevention of C. difficile infection. The U.S. Centers for Disease Control and Prevention (CDC) has identified C. difficile infection as an “urgent public health threat” that occurs mostly in people who have had recent medical care with IV antibiotics. 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 irritable bowel syndrome with constipation (IBS-C), 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 intent to continue the clinical development and evaluations of SYN-004 in a Phase 2a study to evaluate the ability of SYN-004 to degrade residual IV antibiotic in the gastrointestinal (GI) tract, the intended benefits to be achieved from use of SYN-004, including the potential prevention of C. difficile infections, 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: 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 March 19, 2015