Synthetic Biologics reports positive outcome of FDA meeting on SYN-004
Synthetic Biologics has completed an End-of-Phase 2 meeting with the FDA to discuss development of SYN-004 - ribaxamase - for the prevention of antibiotic-mediated Clostridium difficile infection. Pursuant to the meeting, the FDA has proposed criteria for Phase 3 clinical efficacy and safety which, if achieved, may support submission for marketing approval of ribaxamase on the basis of a single Phase 3 clinical trial. Final agreement on these criteria is contingent on FDA evaluation of a detailed Phase 3 clinical trial protocol. Synthetic Biologics, in consultation with the FDA, has confirmed the key elements of the Phase 3 clinical program to support a marketing application for ribaxamase, the company's first-in-class oral enzyme designed to degrade certain intravenous beta-lactam antibiotics within the gastrointestinal tract to prevent microbiome damage, Clostridium difficile infection, overgrowth of pathogenic organisms and the emergence of antimicrobial resistance. The FDA agreed to a primary safety endpoint of noninferiority in mortality between the ribaxamase treatment group versus placebo at 3 months post-randomization. Synthetic Biologics anticipates initiating the Phase 3 clinical program after securing additional potential financing via a strategic partnership.