Synthetic Biologics tanks as it gives up on IBS-C candidate SYN-010

Synthetic Biologics (NYSE American: SYN) today announced disappointing results of a planned interim futility analysis of the investigator-sponsored Phase IIb clinical study of SYN-010 being conducted by Cedars-Sinai Medical Center (CSMC), with the news sending the firm’s shares crashing 34% to $0.31 in early trading this morning.

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. 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 IIb 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 (21mg and 42mg) in patients diagnosed with irritable bowel syndrome with constipation (IBS-C). 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 21mg and 42mg daily doses relative to placebo.