Synthetic Biologics, Inc. plans to initiate a Phase 2b/3 adaptive pivotal trial for SYN-010, the company's modified-release reformulation of lovastatin lactone designed to reduce methane production by certain microorganisms in the gut to treat the underlying cause of irritable bowel syndrome with constipation (IBS-C). The company anticipates initiating this trial by the end of first quarter. The primary objective for this study is to determine the efficacy of SYN-010, measured as an improvement from baseline in the percentage of overall weekly responders during the 12-week treatment period for SYN-010 21 mg and 42 mg daily doses compared to placebo. Secondary efficacy endpoints for both dose strengths of SYN-010 will measure changes from baseline in abdominal pain, bloating, bowel movement frequency and stool consistency. Exploratory outcomes include Adequate Relief and quality of life measures using the well-validated EQ-5D-5L and PAC-SYM patient questionnaires.