Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics designed to preserve the microbiome to protect and restore the health of patients, today announced it 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."

SYN-010 is a proprietary, modified-release formulation of lovastatin lactone (lactone form of lovastatin - lovastatin is the generic name of Merck' Mevacor) that is intended to reduce methane production by certain microorganisms (M. smithii) in the gut while minimizing disruption to the microbiome to treat an underlying cause of IBS-C. SYN-010 is intended to act primarily in the intestinal lumen while avoiding systemic absorption, thereby targeting a major cause of IBS-C, not just the symptoms.