Synthetic Biologics Expands Clinical & Regulatory Leadership Team with Addition of Klaus Gottlieb, MD, FACG

— GI Clinician and Scientist Most Recently Served in Leadership Positions at Quintiles and the U.S. Food & Drug Administration (FDA) —

ROCKVILLE, Md., June 2, 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, announced Klaus Gottlieb, MD, FACG, has joined the Company as Vice President, Clinical & Regulatory Affairs, effective June 22, 2015. Dr. Gottlieb’s appointment expands the clinical and regulatory leadership team as the Company moves into Phase 2 clinical trials for its irritable bowel syndrome with constipation (IBS-C) and C. difficile programs. He will report to Joseph Sliman, MD, MPH, Synthetic Biologics’ Senior Vice President, Clinical & Regulatory Affairs.

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Dr. Gottlieb is an experienced board-certified internist and gastroenterologist with a strong clinical science, business and drug development background. He has led cross-functional teams in a variety of settings in industry, academia, private practice and with the FDA. He joins Synthetic Biologics after serving as Senior Medical Director-Therapeutic Strategy Lead Gastroenterology of Quintiles, a Fortune 500 company and the world’s largest provider of biopharmaceutical development and commercial outsourcing services. At Quintiles, Dr. Gottlieb served as Global Medical Advisor for three separate large Phase 3 inflammatory bowel disease (IBD) trials and provided significant input on the shaping, design and evaluation of numerous IBD and other gastrointestinal (GI) clinical trials throughout all stages of development programs. Prior to joining Quintiles in 2013, he was with the FDA in Silver Spring, MD as a Senior Clinical Reviewer for the Division of Gastroenterology and Inborn Errors Products. Previously, Dr. Gottlieb spent 11 years at Sacred Heart Medical Center, a 500-bed full service hospital in Spokane, WA.

“Klaus Gottlieb’s broad clinical and regulatory experience makes him the ideal candidate to join our team as we prepare to advance several Phase 2 programs in the clinic,” said Dr. Sliman. “His accomplishments in the GI and microbiome areas are critical to Synthetic Biologics’ continued successful product development. We believe Klaus’ knowledge of clinical pathways to commercialize products for the treatment of GI diseases will be especially valuable to us as our team moves the SYN-010 therapeutic program to address IBS-C into Phase 2 later this month, and the SYN-004 program to protect the microbiome and prevent C. difficile infection and antibiotic-associated diarrhea into a Phase 2b during the third quarter of this year.”

Dr. Gottlieb graduated from medical school in 1987 and received a Dr. med. degree from the University of Bonn, Germany, for bench research conducted in Medical Microbiology, a Masters of Business Administration degree from Indiana University in 2000 and a Masters of Science in Biotechnology from Johns Hopkins University in 2012. Widely published, his academic contributions have been recognized by an appointment as Professor of Medicine (Clinical) at George Washington University and the following elected fellowships: Fellow American College of Physicians, Fellow American College of Gastroenterology, Fellow American Society of Gastrointestinal Endoscopy.

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 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

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 expected contribution of Dr. Gottlieb. 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 successfully integrate the new management 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.

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SOURCE Synthetic Biologics, Inc.