Theriva Biologics’ SYN-004 receives positive DSMC review in Phase 1/2 trial

Theriva Biologics announced a positive outcome from the Data and Safety Monitoring Committee – DSMC – review of results from the second Cohort of its Phase 1b/2a clinical trial of SYN-004 – ribaxamase – in allogeneic hematopoietic cell transplant – HCT – recipients for the prevention of acute graft-versus-host-disease, or aGVHD. The study is ongoing and remains blinded; however, key findings from blinded data for Cohort 2 included: no adverse events were determined by the investigators to be related to study drug treatment; a total of 15 SAEs were reported among 10 patients; no patients died within the 30-day follow-up period after the last dose of study drug; 1 patient died 95 days and another 211 days after the last dose of study drug due to cancer relapse and pneumonia respectively. Consistent with the findings from Cohort 1 and previous studies of SYN-004 in healthy volunteers, no patient blood samples were positive for SYN-004 at any timepoint. The pharmacokinetics of piperacillin, which can be metabolized by SYN-004, were as expected for this patient population. Based on a review of the safety and pharmacokinetic data, the DSMC has recommended that the study proceed to enroll Cohort 3.