SYN - Synthetic Bio's lead candidate flunks irritable bowel study; shares down 42%

Synthetic Biologics (SYN) plunges 42% premarket after announcing the results of a planned interim futility analysis of the investigator-sponsored Phase 2b clinical study of SYN-010 being conducted by Cedars-Sinai Medical Center ((CSMC)).It was concluded that although SYN-010 was well-tolerated, it is unlikely to meet its primary objective by the time enrollment is completed. As a result, CSMC has agreed to discontinue the trial and will conduct a comprehensive review of the final data set and publish its findings. The Phase 2b study was designed to evaluate two dose strengths of oral SYN-010 (21 mg and 42 mg) in patients diagnosed with irritable bowel syndrome with constipation (IBS-C). The primary objective was intended to determine the efficacy of SYN-010, measured as an improvement from baseline in the weekly average number of complete spontaneous bowel movements ("CSBMs") during the 12-week treatment period relative to placebo.

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Synthetic Bio's lead candidate flunks irritable bowel study; shares down 42%