— FDA Provides Company with Recommendation and Guidance for Clinical Study Design for Phase 2b/3 Adaptive Trial —
ROCKVILLE, Md., Aug. 2, 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 the completion of an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for SYN-010, designed to treat an underlying cause of the symptoms commonly associated with irritable bowel syndrome with constipation (IBS-C).
Following a review of data from the two Phase 2 clinical trials of SYN-010 conducted by Synthetic Biologics, a collaborative discussion ensued with FDA to determine the optimal pathway to advance SYN-010 into Phase 3 development. With the concepts of the clinical program outlined, Synthetic Biologics was encouraged to work closely with FDA on an adaptive trial design and corresponding statistical analysis plan to support the execution of the first pivotal clinical trial for SYN-010. Further dose exploration and sensitivity analysis of breath methane levels for trial participation are elements that will be addressed in the first pivotal clinical trial for SYN-010.
“The completion of our End of Phase 2 meeting with FDA is an exciting and decisive clinical milestone for Synthetic Biologics. Outcomes from our two Phase 2 clinical trials continue to emphasize the need for the development of a treatment that targets one of the underlying causes of IBS-C and allows us to take the next step in bringing a product to market with the potential to address this largely unmet medical need.” said Jeffrey Riley, Chief Executive Officer. “We were very pleased with the collaborative nature of our meeting with FDA as well as the Agency’s recommendations on the path forward towards a pivotal trial for SYN-010.”
SYN-010 is a proprietary, modified-release formulation of lovastatin lactone that is intended to reduce methane production by certain microorganisms (Methanobrevibacter smithii) in the gut while minimizing disruption to the microbiome to treat an underlying cause of IBS-C. SYN-010 is intended to act primarily in the intestinal tract while minimizing systemic absorption of the cholesterol-lowering metabolite form of lovastatin lactone, thereby targeting a major cause of IBS-C, not just the symptoms. To access the SYN-010 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 in Phase 2 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 and antibiotic-associated diarrhea (AAD). 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.therivabio.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 timing of the interim analysis and the potential benefits of ribaxamse and SYN-010, including statements regarding working closely with FDA on an adaptive trial design and corresponding statistical analysis plan to support the execution of the first pivotal Phase 3 clinical trial for SYN-010, the continued emphasis on the need for development of a treatment that targets one of the underlying causes of IBS-C and the taking of the next steps to bring the product to market with the potential to address an unmet medical need . 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 that 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 August 2, 2016