Results of the SYN-004 Clinical Trial in Hematopoietic Cell Transplant Recipients

At the upcoming Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global), taking place in Vienna, Austria, from April 11th to 15th, 2025, preliminary data on the safety and pharmacokinetics of SYN-004, also known as ribaxamase, will be presented. This event will provide an opportunity for Theriva Biologics, a company focused on developing therapies for cancer and related diseases, to share this information in an electronic poster session.

The presentation will be delivered by Dr. Erik R. Dubberke, Professor of Medicine and Clinical Director of Transplant Infectious Diseases at Washington University in St. Louis. The ePoster, identified as E0145, will focus on the safety and tolerability of SYN-004 in recipients of allogeneic hematopoietic cell transplants who have been treated with the antibiotics meropenem or piperacillin/tazobactam. This analysis will be part of a session dedicated to infections in hemato-oncological patients, scheduled for Saturday, April 12th at 13:30 CEST in Arena 1 of the Messe Wien Exhibition and Conference Center.

The ongoing phase 1b/2a clinical trial is randomized, double-blind, and placebo-controlled, taking place at the University of Washington School of Medicine. Its aim is to evaluate the safety, tolerability, and absorption of SYN-004 in patients who have received transplants and are undergoing treatment with intravenous antibiotics. Participants are divided into three cohorts to assess the effect of different beta-lactam antibiotics, with close monitoring by a Data and Safety Monitoring Committee.

SYN-004 is an oral prophylactic treatment designed to degrade certain beta-lactam antibiotics in the gastrointestinal tract, helping to maintain the balance of the intestinal microbiome. This action is crucial for preventing severe infections, such as those caused by Clostridioides difficile, and reducing the risk of acute graft-versus-host disease in transplant recipients.

Theriva Biologics continues its commitment to researching treatments in areas of high clinical need, including its oncolytic adenovirus platform for cancer treatment. In this context, SYN-004 stands out as a promising option to minimize adverse effects on the intestinal microbiome caused by antibiotic administration in this patient group.

Referrer: MiMub in Spanish

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