Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, announced that its Investigational New Drug (IND) application which was submitted to the US Food and Drug Administration (FDA) in October will be proceeding into clinical trials for the development of the company's oral beta-lactamase enzyme SYN-004 for the prevention of Clostridium difficile (C. difficile) infection (CDI), antibiotic-associated diarrhea (AAD) and secondary infections with healthcare-acquired, drug-resistant pathogens in patients receiving intravenous (IV) beta-lactam antibiotic therapy.

Synthetic Biologics plans to begin phase 1a and 1b clinical trials shortly, with topline data expected to be reported before year-end.

"We are pleased the FDA completed the 30-day review of our IND and to be initiating clinical trials of the first potential point-of-care preventative therapy for C. difficile, the CDC's top-ranking public health threat," said Jeffrey Riley, chief executive officer of Synthetic Biologics. "Taking immediate and aggressive action to develop a therapy that can prevent C. difficile before it starts is critical in addressing this pervasive and life-threatening infection, and IND activation for SYN-004 is a key step toward the development and eventual commercialization of therapy to protect the millions of at risk US patients."



C. difficile is a widespread infection that 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 annuallyi, and the Company believes there is currently no vaccine or drug approved for the prevention of C. difficile infection.



SYN-004 is Synthetic Biologics' oral drug candidate designed to be the first and only prophylactic treatment intended to prevent the development of C. difficile infection, by binding with and neutralizing certain common IV beta-lactam antibiotics in the gut. SYN-004 is intended to block the unintended harmful effects of antibiotics within the gastrointestinal (GI) tract, maintaining the natural balance of the bacterial flora (gut microbiome), potentially preventing the 1.1 million C. difficile infectionsii and 30,000 C. difficile-related deathsiii in the US each year.



Riley added, "In addition to antibiotics being a key trigger in the development of C. difficile infection, research continues to point to the fact that disruption of the gut microbiome due to antibiotic usage, as well as the steady rise in antibiotic-resistant superbugs, are causative factors for a variety of GI, CNS and metabolic disorders, including obesity and diabetes. SYN-004 may be the solution."



Synthetic Biologics has met each milestone for its C. difficile program leading up to the IND submission to the agency. Clinical drug manufacturing of SYN-004 under cGMP guidelines to support Synthetic Biologics' planned phase 1 and 2 clinical trials was completed on time to support the IND submission and clinical trial initiation. Most recently, the US Patent and Trademark Office issued a Notice of Allowance for the first composition of matter patent application directly pertaining to SYN-004 in the US, which carries a patent term to at least 2031.