Synthetic Biologics Receives Orphan Drug Designation for SYN-005 Treatment for Whooping Cough (Pertussis)
-- Company Expects to File IND to Support Clinical Trials in Mid-2015 --
ROCKVILLE, Md., Sept. 12, 2014 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing novel anti-infective biologic and drug programs targeting specific pathogens that cause serious infections and diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to the Company's proprietary SYN-005 monoclonal antibody (mAb) combination for the treatment of Pertussis, more commonly known as whooping cough. In the U.S., Orphan Drug Designation provides a variety of incentives, including seven years of market exclusivity, should SYN-005 receive FDA approval for the treatment of Pertussis.
"Achieving this milestone is an important step in building the foundation for our Pertussis clinical program. The next anticipated milestone for SYN-005 is to initiate cGMP manufacturing in the second half of this year, followed by the filing of an IND in mid-2015 to support the initiation of a Phase I clinical trial," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "We expect this to become an important new treatment option for patients suffering from Pertussis."
Synthetic Biologics is developing SYN-005 through its Exclusive Channel Collaboration with Intrexon Corporation (NYSE: XON) and academic researchers at The University of Texas at Austin to target and neutralize the pertussis toxin in order to reduce morbidity and mortality in infected infants. Pertussis is a highly contagious disease caused by the bacteria Bordetella pertussis (B. pertussis) with symptoms that may include chronic coughing and subsequent breathing difficulties. According to the World Health Organization, there are approximately 50 million worldwide cases of whooping cough each year, leading to an estimated 300,000 deaths, primarily among young, unvaccinated infants.
The Orphan Drug designation is granted to development-stage novel therapeutics that offer potential value in the treatment of rare diseases and medical conditions that affect fewer than 200,000 patients in the US. Orphan Drug designation qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received Orphan Drug designation is not subject to the Prescription Drug User Fee Act (PDUFA) fees unless the application includes an indication for other than the rare disease or condition for which the therapeutic was designated.
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 Synthetic Biologics' next anticipated milestones for SYN-005 for initiation of cGMP manufacturing in the second half of 2014 and the filing of an IND in mid-2015, the expectation of SYN-005 becoming a new treatment option for patients suffering from Pertussis and the market size. 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, the additional clinical studies and results not meeting expectations, our inability to obtain regulatory approval 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.
SOURCE Synthetic Biologics, Inc.
Released September 12, 2014