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

urtis Donskey, M.D., Ciaran Kelly, M.D. and Tom Louie, M.D., formed to support clinical development of SYN-004.
  • Clinical microbiome study in collaboration with Enterome Bioscience expected to begin in second half of 2014.
  • Constipation-Predominant Irritable Bowel Syndrome (C-IBS) – SYN-010 Oral Compound
    Dr. Mark Pimentel of Cedars-Sinai Medical Center (CSMC), led the investigational team whose critical discoveries into the underlying cause of gas, pain and constipation associated with C-IBS established the foundation of Synthetic Biologics' C-IBS program, and are the basis for developing an oral treatment to reduce the impact of methane-producing organisms on conditions such as C-IBS. Of the 40 million IBS patients in the United States[v], approximately 13.2 million have C-IBS[vi].

    C-IBS Operational Highlights and Upcoming Milestones:

  • Initiation of a Phase II dose-discovery and proof-of-mechanism clinical trial of SYN-010 in C-IBS expected during the second half of 2014 under a corporate IND, with topline data expected mid-2015.
  • C-IBS CAB formed with Dr. Mark Pimentel as Chairman; in process of adding other prominent thought leaders and researchers in the field of C-IBS.
  • Synthetic Biologics to host an IBS investor day in New York on September 16, 2014, to provide an overview of the clinical development strategy for SYN-010, with Dr. Pimentel as keynote speaker.
  • Pertussis (Whooping Cough) – SYN-005 Monoclonal Antibody (mAb) Combination
    SYN-005, a unique combination of two humanized antibodies designed to target and neutralize pertussis toxin, a major cause of Pertussis-mediated infant morbidity and mortality, is being developed under an exclusive channel collaboration with Intrexon Corporation (NYSE: XON), and Synthetic Biologics' academic collaborator, The University of Texas at
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    SOURCE Synthetic Biologics, Inc.
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