Synthetic Biologics, a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, and Enterome Bioscience, a developer 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.
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.
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 U.S. C. diff is a multidrug-resistant bacterium that infects 1.1 million U.S. patients annually. In the U.S., patients with C. diff are hospitalized an estimated 3.6 to seven extra days, costing more than $8.2 billion.
“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," said 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."