Synthetic Biologics, Inc. (NYSE American: SYN), announced that the first two patients have been enrolled in SYN-010’s Phase 2b investigator-sponsored clinical study.
SYN-010 is a proprietary, modified-release reformulation of lovastatin lactone 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). Cedars-Sinai Medical Center (CSMC) and Synthetic Biologics are co-funding the study, which will further assess the efficacy and safety of SYN-010 in patients diagnosed with IBS-C.
IBS with constipation can be debilitating for millions of people worldwide, and this study will go a long way toward helping identify whether SYN-010 can become a valuable tool in addressing the underlying causes and offering relief to those patients,
said Mark Pimentel, M.D., head of the Pimentel Laboratory and executive director of the Medically Associated Science and Technology (MAST) Program at CSMC.
The Phase 2b study is being conducted by the MAST Program at CSMC and comprises 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. A data readout from this investigator-sponsored clinical study is expected during the second half of 2019.
We are very excited to begin enrollment of our SYN-010 Phase 2b investigator-sponsored clinical study,
said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics.
SYN-010 remains an integral component in our portfolio of microbiome-focused assets and represents a promising and differentiated approach to treating the underlying cause of the symptoms commonly associated with IBS-C. This study will be instrumental in our efforts to expand and fortify the already well-established dataset for SYN-010 and may 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.
The patent rights covering the use of SYN-010 are owned by Cedars-Sinai Medical Center and are exclusively licensed by Cedars-Sinai Medical Center to Synthetic Biologics. Both Cedars-Sinai and Dr. Pimentel have a financial interest in Synthetic Biologics.