Company’s License from The University of Texas at Austin Covers Development of SYN-005 in Collaboration with Intrexon Corporation
ROCKVILLE, Md., July 21, 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, today announced that Jennifer Maynard, Ph.D., of The University of Texas at Austin’s McKetta Department of Chemical Engineering will highlight Synthetic Biologics’ SYN-005 monoclonal antibody (mAb) combination for the treatment of Pertussis (whooping cough) in a poster presentation. Dr. Maynard is scheduled to present at the Microbial Toxins & Pathogenicity conference held by Gordon Research Conferences on July 20-25, 2014, in Waterville Valley, NH.
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 poster, titled “Rational Design in Immunotherapeutics to Treat Disease Caused by Bordetellae,” will describe the rationale and design of Synthetic Biologics’ proprietary combination of synergistic humanized monoclonal antibodies, known as SYN-005, which is intended to target and neutralize the pertussis toxin. Dr. Maynard will also present the data from murine and non-human primate models of Pertussis using the unique SYN-005 antibody combination.
In April 2014, Synthetic Biologics reported positive preclinical results from non-human primate, Pertussis studies of SYN-005, which were associated with favorable decreases in white blood cell counts within two days of treatment and the achievement of nearly normal levels within one week.
“We are pleased to have Dr. Maynard share the research and strong body of evidence supporting the clinical development of SYN-005,” stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “Based on the positive non-human primate and murine model findings, Synthetic Biologics has begun manufacturing SYN-005, and remains on track to file an IND to support a Phase I clinical trial expected to initiate during the first half of 2015. In addition, we have submitted an Orphan Drug designation request for SYN-005 for the treatment of Pertussis.”
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.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 potential effects of neutralizing pertussis toxin and the expected timing of the Phase I clinical trial. 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 clinical trials and commercialization of Synthetic Biologics’ therapeutics, a failure of Synthetic Biologics’ clinical trials, studies and those conducted by investigators, to be commenced or completed on time or to achieve desired results or results similar to those in the findings from the preclinical studies of SYN-005, a failure of Synthetic Biologics’ clinical trials to receive anticipated funding, a failure of Synthetic Biologics’ candidates for the prevention and treatment of infectious 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, 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 July 21, 2014