Synthetic Biologics, Inc., a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, and Enterome Bioscience SA, a pioneer in the development of innovative disease management solutions based on a deep understanding of the gut microbiome, have entered into an agreement to conduct metagenomic research on the effects of beta-lactam antibiotics on the gastrointestinal microflora (microbiome) of human patients.

As part of this collaboration, a clinical microbiome study of approximately 100 patients is expected to begin next month. Research findings should provide important insights as Synthetic Biologics advances the development of SYN-004, which is intended to protect the gut microbiome from the effects of intravenous (IV) beta-lactam antibiotics, and in particular to prevent C. difficile (C. diff) infections. Phase Ia and Ib clinical trials of Synthetic Biologics' SYN-004 are scheduled to begin later this year.

The Enterome microbiome study, scheduled for completion in the second half of 2014, is expected to provide a better understanding of the harmful effects of beta-lactam antibiotics on the gut bacterial community. The goal is to establish a "fingerprint" of the damage caused by beta-lactam antibiotics, thus yielding a panel of bacterial biomarkers that can be leveraged for diagnostic purposes. This novel study should clearly define the impact of beta-lactam antibiotics on the natural bacterial diversity of the gut microbiome. Changes in the gut microbiome have been related to multiple diseases, including C. diff infections, antibiotic-associated diarrhea, obesity, diabetes and other metabolic diseases. This study will utilize Enterome's state-of-the-art shotgun metagenomic sequencing technology to profile the human gut microbiome.

"We are pleased to establish this collaboration with Enterome, a pioneer in the development of biomarkers and therapies for diseases of the gut microbiome," stated Jeffrey Riley, CEO of Synthetic Biologics. "Findings from this study should support our C. diff therapeutic program, which focuses on protecting and maintaining the balance of bacterial microflora in the gut, while also establishing our presence in Europe."

Synthetic Biologics' lead anti-infective product candidate, SYN-004, is the first therapy designed to neutralize IV antibiotics in the gut, and is intended to protect and maintain the balance of bacterial flora in the gastrointestinal tract, to prevent the devastating effects of C. diff. The U.S. Centers for Disease Control and Prevention (CDC) has classified C. diff as an "urgent public health threat", surpassing Methicillin-resistant Staphylococcus aureus (MRSA) as the number one hospital-acquired infection in the United States. C. diff is a multidrug-resistant bacterium that infects 1.1 million US patients annually. In the US, patients with C. diff are hospitalized an estimated 3.6-7 extra days, costing more than $8.2 billion.

"The signing of this agreement with Synthetic Biologics is another important corporate milestone for Enterome. I am very pleased that our pioneering approach to understanding the linkage between changes in the gut microbiome and disease has convinced Synthetic Biologics to work with us on such an important personalized medicine project. It is clear that new diagnostic solutions are needed to properly address the growing problem of antibiotic-induced dysbiosis and associated hospital-acquired bacterial infections," stated Pierre Belichard, CEO of Enterome. "Tailoring the use of anti-infective treatments based on microbiome profiling is beginning to show great promise as a way to address the management of infectious diseases."

"Comparing Enterome's technology to other genomic analyses of gut microbiome is like comparing a Quad Full High definition color resolution TV to resolution of an analog black & white TV," added  Riley.

Synthetic Biologics is developing SYN-004, a novel second generation oral enzyme drug candidate, to be co-administered with commonly used IV beta-lactam antibiotics and is intended to protect the gastrointestinal microflora (microbiome) from the harmful effects of such antibiotics, thus potentially preventing C. diff infections. Planned next steps for SYN-004 include: 1) initiation of a 28-day bridging toxicology study in June 2014; 2) filing of an Investigational New Drug (IND) application to initiate Phase Ia and Ib clinical trials in the second half of 2014, with preliminary topline data expected by year-end 2014; and, 3) initiation of a phase II efficacy study is expected to begin in the first half of 2015.