Ribaxamase, an Orally-administered ß-lactamase, Protects the Gut Microbiome in Patients Treated with Ceftriaxone

Ribaxamase is an orally-delivered ß-lactamase intended to be co-administered with intravenous ß-lactam antibiotics (penicillins and cephalosporins) to protect the gut microbiome from excess antibiotics excreted into the gastrointestinal tract. In a placebo-controlled, multinational Phase 2b proof-of-concept clinical study, ribaxamase significantly reduced the incidence of Clostridium difficile infection in patients treated with ceftriaxone for a lower respiratory tract infection. Patients could also receive treatment with macrolides at the discretion of the clinician. During the clinical study, three sequential fecal samples were collected for analysis of the gut microbiome and microbiologic determination of intestinal colonization by certain pathogens. Changes in the gut microbiome were analyzed using 16S rRNA gene sequencing.