24/7 Market News- Theriva Biologics Announces Positive DSMC Outcome in Phase 1b/2a Clinical Trial of SYN-004

DENVER, Colo., Oct 03, 2024 (247marketnews.com)- Theriva Biologics (NYSE: TOVX) reported positive Data and Safety Monitoring Committee (DSMC) review of results from the second Cohort of its Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD).

The DSMC recommended that the study proceed to enroll Cohort 3, based on a review of the safety and pharmacokinetic data, in which study drug (SYN-004 or placebo) will be administered in combination with the IV beta-lactam antibiotic cefepime.

Steven A. Shallcross, CEO of Theriva Biologics, stated, “These encouraging data support the clinical advancement of SYN-004 and build on the growing data that underscore its therapeutic potential. The first 2 cohorts have shown that active SYN-004 is not found in the blood of allo-HCT patients after repeated oral doses, in part alleviating the concern that SYN-004 might be absorbed in patients with poor intestinal barrier function and potentially interfere with IV antibiotics. We are very grateful for the tremendous support from Dr. Dubberke and his team at Washington University as we pursue additional funding to enable the conduct of the third cohort and continue with the goal of improving standard treatment for these highly susceptible patients by overcoming existing limitations of broad-spectrum IV beta-lactam antibiotics.”

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