Shallcross, Chief Executive and Financial Officer of Synthetic Biologics. "Approval of the Phase 1b/2a clinical protocol by Washington University's IRB is an important step in pursuing a potentially more cost-effective development strategy for SYN-004, targeting a highly specialized patient population," stated Steven A. Enrollment is expected to begin during the first quarter of 2021, pandemic conditions permitting. The study will also evaluate potential protective effects of SYN-004 on the gut microbiome as well as generate preliminary information on potential therapeutic benefits and patient outcomes of SYN-004 in allogeneic HCT recipients. Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee that will make a recommendation on whether to proceed to the next IV beta-lactam antibiotic. Eight participants in each cohort will receive SYN-004 and four will receive placebo. Study participants will be enrolled into three sequential cohorts, with each receiving a different study-assigned IV beta-lactam antibiotic. The goal of this study is to evaluate the safety, tolerability and potential absorption into the systemic circulation (if any) of 150 mg oral SYN-004 administered to allogeneic HCT recipients who receive an IV beta-lactam antibiotic to treat fever.
Syn stocktwits trial#
The IRB-approved Phase 1b/2a clinical program will be conducted by Washington University and comprise a randomized, double-blinded, placebo-controlled clinical trial of oral SYN-004 in up to 36 evaluable adult allogeneic HCT recipients.
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