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Synthetic Biologics, Inc. (SYN) To Initiate Clinical Trials Of SYN-004 In 4Q 2014 To Prevent Potentially Deadly C. difficile Infections



9/3/2014 3:45:28 PM

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ROCKVILLE, Md., Sept. 2, 2014 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, announced today positive results from its final preclinical toxicology study of SYN-004. Per U.S. Food and Drug Administration (FDA) guidance, this bridging study was required to move the Company's lead anti-infective, second-generation product candidate designed to prevent the devastating effects of Clostridium difficile (C. difficile), toward the clinic.

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The Company is in the final stages of preparing its SYN-004 IND application for submission to the FDA, with the expectation of initiating Phase Ia and Ib clinical trials in the fourth quarter of 2014, and a Phase II efficacy study in the first half of 2015.

"As the need for a preventative for C. difficile infections continues to increase globally, moving our SYN-004 program toward the clinic is more important than ever," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "SYN-004 is unique from other C. difficile preventative approaches in development, as it is designed to protect and maintain the microbiome, and prevent the proliferation and devastating effects of C. difficile infections. Research continues to demonstrate that protection of the microbiome also plays an increasingly important role in the prevention of a variety of GI, metabolic and CNS disorders."

Mr. Riley concluded, "In addition, SYN-004 is provided only when necessary as a patient receives IV antibiotics and is at greatest risk of developing C. difficile. Synthetic Biologics' point-of-care preventative approach contrasts significantly with approaches that require mass vaccination."

In the preclinical toxicology study, oral SYN-004 was safe and well tolerated in a canine model over a 28-day dosing period, showing no evidence of toxicity to date at high, repeated doses exceeding those anticipated to be used during human clinical development. These data support Synthetic Biologics efforts to move into clinical development.

About C. difficile Infections

C. difficile is classified by the CDC as an "urgent public health threat," given its high prevalence and resistance to many drugs used to treat other infections. It affects 1.1 million Americans and causes 30,000 deaths each year,1,2 adding an estimated four to seven hospitalization days per patient3 and $8.2 billion in overall annual hospital costs.4C. difficile infections are strongly associated with the use of IV antibiotics, which are administered to more than 24 million Americans annually to prevent or treat infections.5 These powerful antibiotics can create a harmful imbalance in the gastrointestinal tract by wiping out helpful, "good" bacteria, and allowing C. difficile to grow out-of-control, leading to severe diarrhea, damaging the colon, and in some cases, death.6

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology company focused on the development of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases. The Company is developing an oral biologic to protect the gastrointestinal microflora from the effects of IV antibiotics for the prevention of Clostridium difficile (C. difficile) infection, an oral treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS), a series of monoclonal antibodies for the treatment of Pertussis and Acinetobacter infections, and a biologic targeted at the prevention and treatment of a root cause of a subset of IBS. In addition, the Company is developing an 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 intended effects and potential impact of SYN-004, the timing of the IND filing, initiation of the Phase Ia and Ib clinical studies, the initiation of Phase II efficacy study and the expected size of the market for C. diff therapeutics. 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, our inability to timely commence or complete the clinical trials consistent with our current expectations and otherwise demonstrate the ability of SYN-004 to have a significant impact on mitigating the effects of C. difficile, our ability to successfully manufacture cGMP product, receive regulatory approvals for or to commercialize a new product candidate to prevent C. diff infection and other factors described in Synthetic Biologics' report on Form 10-K for the year ended December 31, 2013 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.

1 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.

2 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.

3 (APIC) National Prevalence Study of Clostridium difficile in U.S. Healthcare Facilities. November 11, 2008.http://hospitalacquiredinfections.blogspot.com/2008/12/november-11-2008-association-for.html Accessed: September 30, 2013.

4 Agency for Healthcare Research and Quality. Healthcare and Cost Utilization Project. Statistical Brief #125. Clostridium difficile Infections (CDI) in Hospital Stays, 2009. January 2012. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb124.pdf Accessed: October 1, 2013.

5 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.

6 Committee to Reduce Infection Deaths Web site http://www.hospitalinfection.org/preventing_cdiff.shtml Accessed: September 30, 2013.

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SOURCE Synthetic Biologics, Inc.



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