On Thursday, Theriva Biologics, Inc. ( TOVX ) revealed the outcome of the Data and Safety Monitoring Committee (DSMC) review of results from the second cohort of its Phase 1b/2a trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients to prevent acute graft-versus-host disease (aGVHD).

Allogeneic hematopoietic cell transplant is a type of bone marrow transplant.

GVHD is a common complication when transplanted donor cells recognize the recipient’s tissues as foreign and attack them.

As per data from Benzinga Pro, the stock is trading higher on a strong session volume of 18.61 million compared to an average volume of 671.35K.

The study is ongoing and remains blinded; however, key findings from blinded data for Cohort 2 are included below:

Adverse events (AEs) and serious adverse events (SAEs) observed in cohort 2 were typical of those observed in allo-HCT patients, and no AEs or SAEs were related to the study drug treatment.A total of 15 SAEs were reported among ten patients, with the most common SAE being infections and infestations, including sepsis.

No patients died within the 30-day follow-up period after the last dose of the study drug; one patient died 95 days and another 211 days after the last dose of the study drug due to cancer relapse and pneumonia, respectively (not related to the study drug).

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 time point.

The pharmacokinetics of piperacillin, which SYN-004 can metabolize, 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, in which SYN-004 or placebo will be administered in combination with the IV beta-lactam antibiotic cefepime.

“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,” said Steven Shallcross, CEO.

Price Action: TOVX stock is up 33.30% at $1.65 at the last check on Thursday.

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