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Synthetic Biologics Initiates SYN-004 Phase 2b Proof-of-Concept Clinical Trial
Last update: 28/09/2015 6:57:03 am
-- Study to Evaluate SYN-004's Ability to Prevent C. difficile Infection and Antibiotic-Associated Diarrhea --
ROCKVILLE, Md., Sept. 28, 2015 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, reported the initiation of its SYN-004 Phase 2b proof-of-concept clinical trial. The clinical trial is intended to evaluate the effectiveness of SYN-004 to prevent C. difficile infection (CDI), C. difficile associated diarrhea (CDAD) and antibiotic-associated diarrhea (AAD) in patients hospitalized for a lower respiratory tract infection and receiving intravenous (IV) ceftriaxone.
C. difficile is the leading type of hospital acquired infection and is frequently associated with IV antibiotic treatment. Beta-lactam antibiotics are a mainstay in hospital infection management, and include commonly used penicillin and cephalosporin antibiotics, such as ceftriaxone. However, antibiotics have the potential to cause harmful effects within the gastrointestinal (GI) tract including disruption of the natural balance of the gut microbiome, leading to 1.1 million CDIs(i) and 30,000 C. difficile-related deaths(ii) in the United States each year.
SYN-004 is Synthetic Biologics' oral prophylactic therapy designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of CDI, AAD and emergence of antibiotic-resistant organisms.
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