Core Viewpoint - Theriva Biologics is presenting interim blinded safety and pharmacokinetic data for SYN-004 at the ESCMID Global Congress, focusing on its potential to prevent acute graft-versus-host disease in allogeneic hematopoietic cell transplant recipients [1][3]. Group 1: Clinical Trial Details - The ongoing Phase 1b/2a clinical trial is randomized, double-blinded, and placebo-controlled, evaluating the safety and tolerability of oral SYN-004 in allogeneic HCT recipients receiving IV antibiotics [3]. - The trial is being conducted at Washington University School of Medicine and aims to enroll up to 36 participants across three cohorts, each receiving different IV beta-lactam antibiotics [3]. - Safety and pharmacokinetic data are reviewed by an independent Data and Safety Monitoring Committee to determine the progression to the next cohort [3]. Group 2: About SYN-004 - SYN-004 (ribaxamase) is designed to degrade certain IV beta-lactam antibiotics in the gastrointestinal tract, maintaining gut microbiome balance and preventing Clostridioides difficile infection and acute graft-versus-host disease [4][6]. - A previous Phase 2b clinical trial with 412 patients showed that SYN-004 protected the gut microbiome from antibiotic-mediated dysbiosis, leading to better maintenance and recovery of the microbiome [4]. Group 3: Company Overview - Theriva Biologics is a diversified clinical-stage company focused on developing therapeutics for cancer and related diseases, with a subsidiary working on an oncolytic adenovirus platform [5][6]. - The company's lead candidates include VCN-01, SYN-004, and SYN-020, targeting various aspects of cancer treatment and microbiome protection [6].
Theriva Biologics Announces Presentation of Data from the Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients