Synthetic Biologics Reports First Patient Dosed in Phase 1b Clinical Trial of SYN-004 for the Prevention of C. Difficile Infection

Synthetic Biologics, Inc.

, a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that enrollment has initiated and the first patient was dosed in a Phase 1b clinical trial of SYN-004, an investigational oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy. The randomized, double-blind, placebo-controlled Phase 1b study, which is now underway at Clinical Pharmacology of Miami, is designed to further evaluate the safety, tolerability and pharmacokinetics of multiple-ascending doses of oral SYN-004 in healthy volunteers. In all, up to 24 healthy adult volunteers will be enrolled into three cohorts, with six participants receiving SYN-004 and two participants receiving placebo in each cohort. In this Phase 1b clinical trial, six volunteers per cohort will receive increasing doses of SYN-004 by cohort, four times a day over a seven-day period. "I'm pleased Synthetic Biologics continues to hit its milestones as outlined earlier this year and look forward to a productive 2015," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "Moving Synthetic Biologics' innovative, point-of-care therapeutic approach to prevent C. difficile infection through clinical development is high priority for the Company. We look forward to reporting topline data from the Phase 1b clinical trial and initiating enrollment in a Phase 2 SYN-004 clinical trial during the first quarter of 2015." The U.S. Centers for Disease Control and Prevention (CDC) has identified C. difficile as an "urgent public health threat" and occurs mostly in people who have had recent medical care with IV antibiotics. These antibiotics can create a harmful imbalance in the gut microbiome by killing "good" bacteria, giving C. difficile a chance to multiply and cause diarrhea, which can lead to dehydration, fever, abdominal pain, cramping, nausea, colitis, and even death. In all, 24 million Americans receive IV antibiotics annually[i]. SYN-004 is Synthetic Biologics' oral drug candidate designed to be the first and only treatment intended to prevent C. difficile infection. Its mechanism of action is to bind with and neutralize certain common IV beta-lactam antibiotics in the gut. During 2012, 14.4 million U.S. patients received approximately 117.6 million doses of IV antibiotics[ii] that could be inactivated in the gastrointestinal (GI) tract by SYN-004. SYN-004 is intended to block the unintended harmful effects of antibiotics within the GI tract, maintaining the natural balance of the bacterial flora (gut microbiome), potentially preventing the 1.1 million C. difficile infections[iii] and 30,000 C. difficile-related deaths[iv] in the United States each year.