On Thursday, Teriba Biologics (NYSE:TOVX) announced its Data and Safety Monitoring Committee (DSMC) review of results from the second cohort of a Phase 1b/2a study of SYN-004 (ribaxasamase) in allogeneic hematopoietic cell transplant (HCT) recipients. The results were revealed. Acute graft vs.Host disease (aGVHD).
Allogeneic hematopoietic cell transplantation is a type of bone marrow transplantation.
GVHD is a common complication when transplanted donor cells recognize recipient tissue as foreign and attack it.
According to the data Benzinga Prothe stock is rising due to strong session volume of 18.61 million, compared to average volume of 6.7135 million.
The study is ongoing but remains blinded. However, key findings from blinded data from Cohort 2 are included below.
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Adverse events (AEs) and serious adverse events (SAEs) observed in cohort 2 were typical of those observed in allogeneic HCT patients, and no AEs or SAEs were related to study drug treatment. A total of 15 SAEs were reported in 10 patients. The most common SAEs are infections and parasitic diseases, including sepsis.
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No patient died within the 30-day follow-up period after the last dose of study drug. One patient died of cancer recurrence and pneumonia 95 days after the last dose of study drug, and the other died 211 days later (unrelated to study drug).
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Consistent with the results of previous SYN-004 studies in Cohort 1 and healthy volunteers, no patient blood samples were positive for SYN-004 at any time point.
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The pharmacokinetics of piperacillin, which can be metabolized by SYN-004, were as expected in this patient population.
Based on a review of safety and pharmacokinetic data, the DSMC recommended that the study proceed to enrolling Cohort 3, in which SYN-004 or a placebo will be administered in combination with the intravenous beta-lactam antibiotic cefepime.
“These encouraging data support the clinical progress of SYN-004 and build on a growing body of data highlighting its therapeutic potential. It has been shown that active SYN-004 is not detected in the blood, which suggests that SYN-004 may be absorbed by patients with impaired intestinal barrier function and may inhibit intestinal barrier function. Our concerns have been partially alleviated. We are administering intravenous antibiotics,” said CEO Steven Shallcross.
Price action: TOVX stock is up 33.30% at $1.65 at last check on Thursday.
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