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news.US-based Synthetic Biologics has dosed the first patient in a second Phase IIa clinical trial of its candidate therapy, SYN-004, to protect the microbiome and prevent C. difficile
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SYN-004 is designed to degrade certain intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract and maintain the natural balance of the gut microbiome for the prevention of C. difficile infection, antibiotic-associated diarrhea (AAD) and secondary antibiotic-resistant infections.
The multi-center, open-label, two-period, fixed-sequence Phase IIa trial is designed to evaluate the GI antibiotic-degrading effects and the safety of SYN-004, in the presence of the proton pump inhibitor (PPI), esomeprazole.
Synthetic Biologics Clinical & Regulatory Affairs senior vice-president Joseph Sliman said: "As participants complete the first Phase IIa clinical trial of SYN-004, they have the option to continue the evaluation of SYN-004 by moving into this second Phase IIa clinical trial.
"Collecting data in this second Phase IIa trial allows us to build a pharmacokinetics (PK) model, a valuable tool when other antibiotics are evaluated in the future.
"We want to clearly demonstrate the ability of SYN-004 to degrade antibiotics in the gut, to protect the microbiome from the damaging effects of antibiotics and dramatically reduce C. difficile infections through prevention vs. treatment.
"We remain on track to complete and report preliminary data from the first Phase IIa clinical trial within the month, and to initiate the Phase 2b clinical trial in the third quarter of this year."
Around 20 healthy participants with functioning ileostomies will be enrolled in the second Phase IIa trial, which will include two treatment periods for all participants.
Participants are expected to be enrolled at about four trial sites in the US and Canada.
The two treatment periods include the administration of SYN-004 and IV ceftriaxone, and the administration of SYN-004 and IV ceftriaxone in the presence of esomeprazole, an approved, over-the-counter PPI.
The company said that chyme samples will be collected from the participants to measure the ability of SYN-004 to degrade the residual antibiotic.