Irritable Bowel Syndrome (IBS- Pediatric)

June 6, 2016

Synthetic Biologics reported results of two phase II trials of SYN-010 for irritable bowel syndrome with constipation (IBS-C). The two SYN-010 trials were comprised of a randomized, double-blind, placebo-controlled, four-week study comparing SYN-010 21mg and 42mg dose strengths to placebo (study 1), followed by an open-label study in which eligible patients who completed study 1 received SYN-010 42mg for an additional eight weeks (study 2). The two trials evaluated the change from baseline (day 1 of study 1) in breath methane, stool frequency and abdominal pain and bloating at the end of weeks one, four, eight and 12 (study 2 to day 84) in patients diagnosed with IBS-C and with breath methane levels greater than 10 parts per million at screening. Clinical data from patients who completed study 1 (n=63) and study 2 (n=54) showed clinically meaningful improvements in measurable endpoints, including an increase from study 1 baseline to the end of study 2 in the percentage of patients identified as Monthly Responders, an FDA-defined composite measure incorporating improvements in CSBMs and abdominal pain. Data demonstrated an inverse correlation (p=0.026) between breath methane area under the curve (AUC) and complete spontaneous bowel movements (CSBM). A similar inverse correlation (p=0.003) was observed between breath methane AUC and spontaneous bowel movements (SBM). Clinical data from study 1 demonstrates that patients in both the 21mg and 42mg SYN- 010 treatment groups used 60% less rescue medication (bisacodyl; 5mg) when compared to placebo. A phase III trial is planned for later this year.