Based on FDA feedback, a single-center three-arm Phase 1b/2a clinical trial, expected to start this quarter, will assess SYN-004 in up to 36 adults patients undergoing allogeneic hematopoietic cell transplantation (HCT) who have received intravenous beta-lactam antibiotics in response to fever. The primary objectives are safety, tolerability and pharmacokinetics.
The study will be conducted at the Washington University School of Medicine in St. Louis.
SYN-004 is an oral enzyme tablet that is co-administered with the antibiotics. By degrading beta-lactams, it helps maintain the normal balance of the gut microbiome and prevents unwanted effects such as diarrhea and Clostridium difficile infection.
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