What is it about?
A well balanced gut microbiome is essential for human health, and disruption of this balance can lead to many health issues. Antibiotics are, perhaps, the most disruptive influence on the gut microbiome. SYN-004 (ribaxamase) is an orally administered enzyme which is intended to be taken with intravenous beta-lactam antibiotics to protect the gut microbiome from these potent antibiotics thus preventing serious side effects like Clostridium difficile infection. This manuscript demonstrates that ribaxamase is capable of degrading excess beta-lactam antibiotics in the human intestine.
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Why is it important?
One of the most serious side effects associated with antibiotic-mediated disruption of the gut microbiome is Clostridium difficile infection (CDI), but there are currently no licensed products for prevention of this serious gastrointestinal infection. SYN-004 (ribaxamase) has the potential to be one of the first products specifically licensed to prevent CDI in people receiving IV beta-lactam antibiotics.
Perspectives
The Phase 2a studies detailed in this manuscript used a unique study population, people with functioning ileostomies. This population allowed us to non-invasively obtain serial samples of intestinal chyme to confirm the in vivo mechanism of action of ribaxamase, degradation of beta-lactam antibiotics in the human intestine. Successful completion of these Phase 2a studies gave us confidence to proceed into a Phase 2b clinical study designed to determine whether co-administration of oral ribaxamase can protect patients receiving IV ceftriaxone from Clostridium difficile infection.
Dr John F Kokai-Kun
Synthetic Biologics, Inc.
Read the Original
This page is a summary of: The Oral β-Lactamase SYN-004 (Ribaxamase) Degrades Ceftriaxone Excreted into the Intestine in Phase 2a Clinical Studies, Antimicrobial Agents and Chemotherapy, January 2017, ASM Journals,
DOI: 10.1128/aac.02197-16.
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