Positive results from its final preclinical toxicology study of SYN-004 have led Synthetic Biologics to get ready for clinical trials of the anti-infective, second-generation product candidate for Clostridium difficile (C. difficile).

Synthetic Biologics is in the final stages of preparing its SYN-004 IND application for submission to the FDA, with the expectation of initiating Phase Ia and Ib clinical trials in the fourth quarter of 2014, and a Phase II efficacy study in the first half of 2015.

C. difficile is classified by the CDC as an "urgent public health threat," given its high prevalence and resistance to many drugs used to treat other infections. It affects 1.1 million Americans and causes 30,000 deaths each year,adding an estimated four to seven hospitalization days per patient and $8.2 billion in overall annual hospital costs. C. difficile infections are strongly associated with the use of IV antibiotics, which are administered to more than 24 million Americans annually to prevent or treat infections.

Powerful antibiotics can create a harmful imbalance in the gastrointestinal tract by wiping out helpful, "good" bacteria, and allowing C. difficile to grow out-of-control, leading to severe diarrhea, damaging the colon, and in some cases, death.  In the preclinical toxicology study, oral SYN-004 was safe and well tolerated in a canine model over a 28-day dosing period, showing no evidence of toxicity to date at high, repeated doses exceeding those anticipated to be used during human clinical development. The data support efforts to move into clinical development, the company says.

"As the need for a preventative for C. difficile infections continues to increase globally, moving our SYN-004 program toward the clinic is more important than ever," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "SYN-004 is unique from other C. difficile preventative approaches in development, as it is designed to protect and maintain the microbiome, and prevent the proliferation and devastating effects of C. difficile infections. Research continues to demonstrate that protection of the microbiome also plays an increasingly important role in the prevention of a variety of GI, metabolic and CNS disorders.

"In addition, SYN-004 is provided only when necessary – as a patient receives IV antibiotics and is at greatest risk of developing C. difficile. Synthetic Biologics' point-of-care preventative approach contrasts significantly with approaches that require mass vaccination."

Source: Synthetic Biologics, Inc.