Synthetic Biologics Inc. reported that the second Phase 2 clinical trial of its proprietary SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C) met its primary endpoint. Topline data from all patients who completed the second Phase 2 clinical trial of SYN-010 showed a statistically significant decrease in methane production (p=0.002) from the beginning of the first Phase 2 study to the end of the second Phase 2 study, thus meeting the study's primary endpoint. There were no serious adverse events observed.

Topline data from the second Phase 2 study also showed improvements in secondary efficacy endpoints, including: A statistically significant reduction in the mean IBS Symptom Severity Score, An increase in the percentage of patients identified as Monthly Responders, an FDA-defined composite measure incorporating improvements in complete spontaneous bowel movements and abdominal pain. This second Phase 2, open-label SYN-010 clinical trial was conducted for eight weeks at multiple centers in the United States. The primary endpoint of this extension study was to evaluate the sustainability of the effect of one daily dose strength (42 mg) of SYN-010 on breath methane production in breath methane-positive patients with IBS-C. Secondary endpoints included evaluation of the reduction in abdominal pain and bloating, the improvement in stool frequency and overall quality of life.

Fifty-four patients, who completed the first Phase 2 clinical trial of SYN-010 rolled over into the second Phase 2 clinical trial of SYN-010.