- Synthetic Biologics (NYSE:SYN) has entered into an agreement with Cedars-Sinai Medical Center for an investigator-sponsored Phase 2 clinical study of SYN-010.
- The study will further evaluate the efficacy and safety of SYN-010, a modified-release reformulation of lovastatin lactone, which is exclusively licensed by Cedars-Sinai Medical Center.
- The 12-week, placebo-controlled Phase 2 study will evaluate two dose strengths of oral SYN-010 (21 mg and 42 mg) in ~150 patients diagnosed with IBS-C. The enrollment is expected to begin during Q4.
- The primary objective is to determine the efficacy of both the doses of SYN-010, measured as an improvement from baseline in the weekly average number of complete spontaneous bowel movements (CSBMs) relative to placebo.
- Secondary efficacy endpoints are to measure changes from baseline in abdominal pain, bloating, stool frequency as well as the use of rescue medication relative to placebo.
- SYN-010 is designed to reduce methane production by certain microorganisms (M. smithii) in the gut to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C).
- Shares are up 6% premarket.