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Synthetic Biologics Reports Second Quarter 2014 Financial Results and Operational Highlights
Date:8/14/2014

174;, Rebif®, Gilenya®, Aubagio® and Tecfidera®, is currently enrolling patients at four sites in the United States.
  • Synthetic Biologics continues discussions to attract a strategic partner to accelerate development of this innovative therapy for relapsing-remitting MS in women.
  • Prevention of C. difficile (C. diff.) Infections – SYN-004 Oral Enzyme
    SYN-004, Synthetic Biologics' lead anti-infective product candidate, is believed to be the first and only therapy designed to neutralize intravenous (IV) antibiotics in the gut. It is intended to protect and maintain the balance of bacterial flora in the gastrointestinal tract, to potentially prevent the devastating effects of C. diff.  The U.S. Centers for Disease Control and Prevention (CDC) has classified C. diff as an "urgent public health threat", surpassing Methicillin-resistant Staphylococcus aureus (MRSA) as the number one hospital-acquired infection in the United States. C. diff is a multidrug-resistant bacterium that infects 1.1 million U.S. patients annually,[iii] and 30,000 patients die with a C. diff infection annually[iv].

    C. diff Operational Highlights and Upcoming Milestones:

  • Completion of final preclinical toxicology study and subsequent filing of an Investigational New Drug (IND) application in anticipation of human clinical development expected in the upcoming quarter.
  • Initiation of Phase Ia and Ib clinical trials expected in the fourth quarter of 2014, with preliminary topline data expected by year-end 2014.  A Phase II efficacy study is expected to begin in the first half of 2015.
  • Clinical drug manufacturing of SYN-004 in accordance with GMP guidelines is currently underway pursuant to execution of an agreement with Evonik.
  • C. diff Clinical Advisory Board (CAB) comprised of industry leaders Mark Wilcox, M.D., (Chairman), C
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  • SOURCE Synthetic Biologics, Inc.
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