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Trial to evaluate SYN-004 for C. difficile, antibiotic-associated diarrhea prevention
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A phase 2b proof-of-concept clinical trial has been initiated to evaluate the efficacy of SYN-004 for preventing Clostridium difficile infection, and C. difficile- and antibiotic-associated diarrhea among hospitalized patients with lower respiratory infections receiving IV ceftriaxone, the manufacturer announced.
SYN-004 (Synthetic Biologics) is an oral treatment for preventing C. difficile infection, antibiotic-associated diarrhea and the development of antibiotic-resistant organisms by degrading certain antibiotics in the GI tract to balance the gut microbiome, according to a press release.
“Initiating the SYN-004 phase 2b clinical trial is an important milestone for Synthetic Biologics as it is intended to assess the proof-of-concept of SYN-004, which is designed to protect the microbiome and prevent [C. difficile infections and antibiotic-associated diarrhea],” Jeffrey Riley, CEO of Synthetic Biologics, said in the press release. “Several phase 2b clinical sites are open for enrollment and actively screening for patients with additional sites expected to open as we approach the cold and flu season.”
The phase 2b trial is a parallel-group, double-blind, placebo-controlled study, which is expected to recruit an estimated 370 patients from as many as 75 clinical sites across the world, according to the press release. Patients aged 50 years and older who are hospitalized for a lower respiratory tract infection will be randomly assigned to receive either SYN-004 or placebo during standard of care ceftriaxone regimens (with or without a macrolide). The primary endpoint is the efficacy of SYN-004 for preventing C. difficile infection and C. difficile-associated diarrhea, and the secondary endpoint is its efficacy in preventing antibiotic-associated diarrhea.
“Before initiating the SYN-004 phase 2b clinical trial, safety and tolerability was demonstrated in two phase 1 studies: a single-ascending dose study and a multiple-ascending dose study,” Riley said. “Full analysis was completed and study reports were submitted to the FDA.”
Phase 2a clinical trials are also assessing the safety of SYN-004 and its antibiotic-degrading effects with and without esomeprazole in patients with ileostomies, aiming to collect further pharmacokinetics and pharmacodynamics data, and to evaluate potential drug-drug interactions, Riley added.
“We have now enrolled enough participants to complete the first phase 2a trial analysis, even though the recruitment of qualified ileostomized participants was slower than anticipated,” Riley said in the press release. “We are very grateful to these at-risk participants for being a part of these studies and helping us further the development of SYN-004 for the prevention of [C. difficile infections and antibiotic-associated diarrhea]. The phase 2a studies are ongoing and we will report topline data from each of them when full data analysis is available. We anticipate results will be consistent with our expectations and the positive [pharmacokinetic] and safety results demonstrated in the SYN-004 phase 1a and 1b studies previously reported in March 2015, and in the first four participants in the first phase 2a previously reported in July 2015.”
Disclosures: Riley reports he is an employee of Synthetic Biologics.