FDA greenlights clinical trials of SYN-004 for preventing C. diff infection

The FDA has determined that the developer of SYN-004 for the prevention of Clostridium difficile infection is safe to proceed with clinical trials under its investigational new drug application, the manufacturer announced today.

“We are pleased the FDA completed the 30-day review of our [investigational new drug application] 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,” Jeffrey Riley, CEO of Synthetic Biologics, said in the release. “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 U.S. patients.”

SYN-004 (Synthetic Biologics) is an oral beta-lactamase enzyme for preventing C. difficile infection (CDI), antibiotic-associated diarrhea and secondary nosocomial infections with drug-resistant pathogens in patients receiving IV beta-lactam antibiotic therapy, the release said. Designed to be the first and only prophylactic therapy for CDI, SYN-004 is intended to block harmful gastrointestinal effects of antibiotics and balance the gut microbiome by binding with and neutralizing certain IV beta-lactam antibiotics.

“In addition to antibiotics being a key trigger in the development of [CDI], 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,” Riley said in the release. “SYN-004 may be the solution.”

Phase 1a and 1b trials will soon be initiated, with data expected to be reported before the end of the year, the release said.