Theriva Biologics announced the presentation of interim safety and pharmacokinetic data from its ongoing Phase 1b/2a clinical trial of SYN-004 (ribaxamase). The data, focusing on the drug’s use in allogeneic hematopoietic cell transplant (HCT) recipients to prevent acute graft-versus-host-disease (aGVHD), will be presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) Congress. The presentation will detail the safety and tolerability of SYN-004 in patients receiving either meropenem or piperacillin/tazobactam.
This research is crucial because it addresses a significant challenge in HCT: managing the delicate balance between preventing infections and preserving the gut microbiome. Current broad-spectrum antibiotics, while necessary to combat infections in immunocompromised patients, can disrupt the gut microbiome, leading to complications like •Clostridioides difficile• infection, antimicrobial resistance, and aGVHD. SYN-004’s potential to degrade specific antibiotics within the GI tract, thereby protecting the gut microbiome, offers a novel approach to mitigating these risks and improving patient outcomes following HCT.
The Phase 1b/2a trial is evaluating the safety, tolerability, and absorption of SYN-004 in HCT recipients receiving different IV antibiotics. The trial is divided into three cohorts, each assessing a different antibiotic (meropenem, piperacillin/tazobactam, and cefepime) to determine SYN-004’s interaction and efficacy. An independent Data and Safety Monitoring Committee reviews the data from each cohort before proceeding to the next. The trial also aims to explore the drug’s impact on the gut microbiome and gather preliminary data on its potential therapeutic benefits.
Positive data from this trial could significantly advance the field of HCT by offering a proactive strategy to protect the gut microbiome during antibiotic treatment. This could lead to a reduction in complications, improved quality of life for HCT recipients, and potentially lower healthcare costs associated with managing these complications. The next steps involve completing all three cohorts of the study, analyzing the full dataset, and potentially moving toward later-stage clinical trials to further evaluate SYN-004’s efficacy and safety in a larger patient population. The success of SYN-004 could represent a paradigm shift in the management of HCT patients, offering a new tool to minimize the risks associated with essential antibiotic therapies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
