Synthetic Biologics is teaming up with gut microbiome specialists Enterome Bioscience to conduct metagenomic research on the effects of beta-lactam antibiotics on the gastrointestinal microflora of human patients. The two firms say they plan to begin their 100-patient study next month and hope to have it completed in the second half of 2014.
The aim of the Enterome microbiome study is to establish a fingerprint of the damage caused by beta-lactam antibiotics on the human gut microbiome in order to come up with a panel of bacterial biomarkers for diagnostic purposes. Enterome will be using its shotgun metagenomic sequencing technology to profile the human gut microbiome.
Synthetic Biologics is in the process of developing SYN-004, which the firm describes as the first therapy designed to neutralize IV antibiotics in the gut. SYN-004 is intended to protect the gut microbiome from the effects of intravenous beta-lactam antibiotics and also to prevent C. difficile infections. The firm believes this research agreement with Enterome may provide new insights that may aid in advancing the anti-infective candidate. Phase Ia and Ib trials for SYN-004 are currently slated to start later this year.
"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," Enterome's CEO Pierre Belichard said in a statement. "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."