Synthetic Biologics has entered into an agreement with Cedars-Sinai Medical Center for an investigator-sponsored Phase 2 clinical study of SYN-010. The study will provide further evaluation of the efficacy and safety of SYN-010, the Company's modified-release reformulation of lovastatin lactone, which is exclusively licensed to the Company by Cedars-Sinai Medical Center. 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).
The Phase 2 study will be conducted out of the Pimentel Laboratory at Cedars-Sinai Medical Center and is expected to be comprised of a 12-week, placebo-controlled, double-blind, randomized clinical trial to evaluate two dose strengths of oral SYN-010 (21 mg and 42 mg) in approximately 150 patients diagnosed with IBS-C. The investigator-sponsored Phase 2 clinical study will be led by the gastrointestinal microbiota researcher Ruchi Mathur, M.D., director of Metabolism, Clinical Research and Administrative Operations at the Medically Associated Science and Technology (MAST) Program at Cedars-Sinai. The Phase 2 study, which will be co-funded by Synthetic Biologics and Cedars-Sinai Medical Center, is expected to begin enrollment during the fourth quarter of 2018, contingent upon approval of the clinical study protocol by the Cedars-Sinai Medical Center Institutional Review Board. Both Cedars-Sinai and Dr. Pimentel have a financial interest in Synthetic Biologics.
"This research collaboration is a further demonstration of Cedars-Sinai's support for the advancement of promising therapies that harness the power of the microbiome to treat GI disorders such as IBS-C," said Mark Pimentel, M.D., head of the Pimentel Laboratory and executive director of the MAST Program. "By targeting a major cause of IBS-C, SYN-010 has the potential to provide long-term, chronic relief to millions of patients who, to date, are forced to settle for therapies designed to treat the symptoms of IBS-C, but do little to treat the underlying problem."
"We are delighted that Dr. Pimentel and Cedars-Sinai share our view on the potential of SYN-010 as a new and efficacious treatment option for IBS-C," said Steven A. Shallcross, Interim Chief Executive Officer of Synthetic Biologics. "In addition to expanding and fortifying our well-established clinical dataset for SYN-010, the study is also intended to help determine the optimal dose strength of SYN-010 for potential future registration studies."
The primary objective for the study will be 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 21 mg and 42 mg daily doses relative to placebo. Secondary efficacy endpoints for both dose strengths of SYN-010 are expected to measure changes from baseline in abdominal pain, bloating, stool frequency as well as the use of rescue medication relative to placebo. Exploratory outcomes include Adequate Relief and quality of life measures using the well-validated EQ-5D-5L and PAC-SYM patient questionnaires.