First Participant Dosed in Synthetic Biologics' Second Phase 2a Clinical Trial to Protect the Microbiome and Prevent C. difficile

Synthetic Biologics, Inc. (NYSE MKT:

), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, dosed the first participant in a second Phase 2a clinical trial of SYN-004. This trial will evaluate the gastrointestinal (GI) antibiotic-degrading effects and the safety of SYN-004, in the presence of the proton pump inhibitor (PPI), esomeprazole. SYN-004 is the Company's candidate therapy designed to degrade certain intravenous (IV) beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of C. difficile infection, antibiotic-associated diarrhea (AAD) and secondary antibiotic-resistant infections. Synthetic Biologics, Inc. Logo. 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 unintended harmful effects within the GI tract, including disruption of the natural balance of the gut microbiome, leading to 1.1 million C. difficile infections[i] and 30,000 C. difficile-related deaths[ii] in the United States each year. PPIs are often used prophylactically in hospitalized patients. Therefore, with guidance from the U.S. Food and Drug Administration (FDA), Synthetic Biologics is conducting this study to demonstrate the ability of SYN-004 to degrade an intravenous (IV) antibiotic in the presence of a PPI. "As participants complete the first Phase 2a clinical trial of SYN-004, they have the option to continue the evaluation of SYN-004 by moving into this second Phase 2a clinical trial," stated Joseph Sliman, M.D., M.P.H., Senior Vice President, Clinical & Regulatory Affairs of Synthetic Biologics. "Collecting data in this second Phase 2a trial allows us to build a pharmacokinetics (PK) model, a valuable tool when other antibiotics are evaluated in the future. We want to clearly demonstrate the ability of SYN-004 to degrade antibiotics in the gut, to protect the microbiome from the damaging effects of antibiotics and dramatically reduce C. difficile infections through prevention vs. treatment. We remain on track to complete and report preliminary data from the first Phase 2a clinical trial within the month, and to initiate the Phase 2b clinical trial in the third quarter of this year." This second Phase 2a multi-center, open-label, 2-period, fixed-sequence study is expected to evaluate the ability of SYN-004 to degrade residual IV ceftriaxone in the GI tract in the presence of a PPI in up to 20 healthy participants with functioning ileostomies. The study consists of two treatment periods for all participants: 1) the administration of SYN-004 and IV ceftriaxone, and 2) the administration of SYN-004 and IV ceftriaxone in the presence of esomeprazole, an approved, over-the-counter PPI. Chyme samples will be collected from the participants to measure the ability of SYN-004 to degrade the residual antibiotic. Participants are expected to be enrolled at up to four trial sites located in the United States and Canada.