Synthetic Biologics – SYN – To Acquire Clinical-Stage C. difficile Infectious Disease Program

Synthetic Biologics, Inc. (NYSE : SYN), a developer of synthetic biologics and innovative medicines for serious infections and diseases, announced that the Company has entered into an agreement with Prev AbR LLC to acquire its clinical-stage and related beta-lactamase assets targeted for the prevention of Clostridium difficile (C. diff) infection, the leading cause of hospital acquired infections (HAI), that may occur secondary to treatment with antibiotics. The assets include a pre-Investigational New Drug (IND) package, Phase I and Phase II clinical data, manufacturing process data and all issued and pending U.S. and international patents intended to support an IND and Biologic License Application (BLA) with the FDA.

Beta-lactamase enzymes have the ability to degrade beta-lactam antibiotics that may be excreted into the GI tract. Beta-lactam antibiotics are a mainstay in hospital infection management and include both penicillins and cephalosporins. In 2011, an estimated 8.7 million Americans were administered intravenous beta-lactam antibiotics.[1] Utilizing the acquired biologic compounds, Synthetic Biologics intends to develop and commercialize a proprietary oral beta-lactamase enzyme product candidate, SYN-004. When co-administered with beta-lactam antibiotics in a hospital setting, it is expected that SYN-004 can preserve a patient’s gastrointestinal (GI) microflora, thus preventing opportunistic C. diff infection (CDI).

“We are pleased to add the C. diff program to our infectious disease pipeline that also includes an acinetobacter infection program. The need for an alternative mechanism of action to prevent the devastating effects of C. diff infection is critical. It is important to both improve patient care and to combat the burden of rising medical costs associated with hospital-acquired infections such as C. diff,” stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “Current therapies to treat C. diff are not universally effective and efforts to stop the spread of the disease have proven challenging. With regulatory discussions already initiated, we are designing a regulatory pathway for our new product, SYN-004, that is intended to lead to a Phase II clinical trial as soon as possible. We look forward to reporting progress from our C. diff program when milestones are achieved.”

About Synthetic Biologics, Inc. – SYN

Synthetic Biologics (SYN) is a biotechnology company focused on the development of product candidates for serious infections and diseases. SYN is developing a biologic for the prevention of C. diff infection, and a series of monoclonal antibodies (mAbs) for the treatment of serious infectious diseases, including Acinetobacter. SYN is also developing a synthetic DNA-based therapy for the treatment of pulmonary arterial hypertension (PAH). In addition, SYN is developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, and designing a clinical development pathway for the treatment of amyotrophic lateral sclerosis (ALS).

More Posts by this author

• Stocks Extend Losses in Early Trade
• Sirona – SIRO – Record Fiscal 2012 Fourth Quarter and Full Year Results
• Physicians Formula (FACE) and Markwins Amend Merger Agreement
• White River Capital – RVR – To Be Acquired by Parthenon Capital Partners
• American Equity – AEL – Declares Annual Cash Dividend on Common Stock
• MTS Systems Corporation – MTSC – Delivered on revenue and EPS guidance projections for the year
• Ruckus Wireless – RKUS – Announces Pricing of Initial Public Offering

Post Written By: Ed Liston Ed Liston is a senior contributing editor at TheStockMarketWatch.com. An active market watcher and investor, Ed guides an independent team of experienced analysts and writes for multiple stock trader publications. He is widely quoted in various financial publications on the Internet. When Ed is not writing about stocks, investing in stocks, talking about stocks, or otherwise doing something stock related, he likes to go sailing and fishing in his yacht.