Synthetic Biologics (SYN) Completes SYN-004 Phase 2b Enrollment

September 20, 2016 7:08 AM EDT

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Synthetic Biologics, Inc. (NYSE: SYN) announced that following the completion of a previously planned interim analysis by an independent Interim Analysis Committee (IAC), enrollment has been completed in its Phase 2b randomized, placebo-controlled, proof-of-concept clinical trial for SYN-004 (ribaxamase).

Following a closed session with the IAC in which the Company remained blinded to the study data, a recommendation was given to continue the study per protocol without modification and no safety issues were identified. Successful enrollment of 413 patients has occurred exceeding the desired sample size of 372 patients outlined per the study protocol. All ongoing patients are expected to continue through the follow-up period in order to complete the study. The Company anticipates announcing top-line results during the first quarter of 2017.

"The completion of enrollment in our Phase 2b proof-of-concept study for ribaxamase represents a critical milestone for the company and one that exhibits our continued focus of moving our innovative approach to preventing CDI, AAD and antibiotic resistance into late-stage clinical development," said Jeffrey Riley, President and Chief Executive Officer. "We would like to thank the patients and clinical sites that are participating in this study as well as our colleagues for their commitment and dedication to this important and potentially groundbreaking clinical trial. We look forward to announcing top-line results during the first quarter of 2017."

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