Shallcross, Chief Executive Officer of Synthetic Biologics. Although the results were disappointing for SYN-010, we remain committed to the development of new life changing medications for GI diseases" said Steven A. "We are grateful to the patients and Cedars-Sinai who supported this clinical trial. The primary objective of the study 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 for SYN-010 21 mg and 42 mg daily doses relative to placebo. The Phase 2b study was being conducted by the Medically Associated Science and Technology (MAST) Program at CSMC and 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).
#Syn stocktwits trial
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.
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Based on the review of the interim analysis, it was concluded that although SYN-010 was well-tolerated, it is unlikely to meet its primary objective by the time enrollment is completed. Synthetic Biologics has announced 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).