Theriva Advances Clinical Trial with Positive Data

Highlights

• Theriva Biologics reported positive safety and pharmacokinetic data from the second cohort of its ongoing clinical trial for SYN-004, designed to prevent acute graft-versus-host disease in allogeneic hematopoietic cell transplant patients. 
• The trial enrolled patients receiving beta-lactam antibiotics, with results indicating no adverse drug-related events, supporting the continuation to the third cohort of the study. 
• The absence of SYN-004 in patient blood samples reassures researchers that the drug does not interfere with intravenous antibiotic treatments in this vulnerable patient population. 

Theriva Biologics Inc., a clinical-stage company focusing on therapeutics for cancer and related diseases In Healthcare Sector, announced positive outcomes from its ongoing Phase 1b/2a clinical trial of SYN-004 (ribaxamase). SYN-004 is being developed to prevent acute graft-versus-host disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. This treatment addresses a significant unmet medical need in transplant care, where infection and complications pose serious risks to patients. 

Positive Results Of Theriva (NYSE: TOVX) from Cohort 2 

The second cohort of the study included 19 patients, with participants randomized to receive either SYN-004 or a placebo alongside intravenous beta-lactam antibiotics (piperacillin/tazobactam). Data revealed no drug-related adverse events or serious adverse events, which are common concerns for patients undergoing HCT procedures. A total of 15 serious adverse events were reported among 10 patients, with infections and sepsis being the most prevalent. However, none of these events were linked to the administration of SYN-004. 

Additionally, no deaths occurred within the 30-day follow-up period after treatment, and the safety profile observed in the trial supports the continuation of the study. Two deaths occurred after the 30-day period, attributed to unrelated causes such as cancer relapse and pneumonia. 

Absence of SYN-004 in Blood Samples 

A crucial finding from the trial was the absence of SYN-004 in patient blood samples, consistent with earlier studies. This result alleviates concerns that SYN-004 might be absorbed into the bloodstream in patients with compromised intestinal barriers, which could interfere with intravenous antibiotic treatments. The pharmacokinetic profile of piperacillin was also as expected for this patient population, further reinforcing the safety of SYN-004. 

Study Progression to Cohort 3 

Based on the encouraging safety and pharmacokinetic data, the Data and Safety Monitoring Committee (DSMC) has recommended that the study proceed to its third cohort. In this next phase, SYN-004 or placebo will be administered alongside the beta-lactam antibiotic cefepime, expanding the study’s scope to further validate the safety and efficacy of SYN-004 in preventing aGVHD in transplant patients. 

Theriva Biologics continues to demonstrate progress in its mission to improve therapeutic outcomes for high-risk patients, with SYN-004 offering a promising solution to address limitations in current treatment approaches for transplant recipients.