Upon issuance, this patent will strengthen the intellectual property estate covering the use of SYN-010 for the treatment of IBS-C until at least 2034, affording the Company an extended term for commercialization.
US Patent Application No. 14/776,465, which is owned by Cedars-Sinai Medical Center (CSMC) and exclusively licensed to Synthetic Biologics, is based on innovative research led by Mark Pimentel, M.D., FRCP(C), Program Director of CSMC's Medically Associated Science and Technology (MAST) Program and Chairman of Synthetic Biologics' IBS-C Clinical Advisory Board, which correlates methane production in the gut by certain microorganisms (M. smithii) with symptoms commonly associated with IBS-C.
The allowance of this new patent expands the SYN-010 intellectual property portfolio to approximately 55 issued US and foreign patents. In addition, there are approximately 25 US and foreign patents pending, which upon issuance should further strengthen the intellectual property position surrounding SYN-010.
"Once issued, this patent will extend the protection around the use of SYN-010 to treat IBS-C by an additional eleven years and significantly strengthens the opportunity to build long-term value for our shareholders," said Jeffrey Riley, President and Chief Executive Officer of Synthetic Biologics. "We remain focused on the continued clinical advancement of SYN-010 and are encouraged that we are making excellent progress in providing patients with a novel, potentially best-in-class therapy that directly targets an underlying cause of the symptoms associated with IBS-C."
Previously announced results from phase 2 clinical trials conducted by Synthetic Biologics demonstrated SYN-010 significantly reduced abdominal pain and bloating while also improving stool frequency and quality of life scores without severe adverse events in IBS-C patients. Following collaborative discussions with the US Food and Drug Administration (FDA), the Company announced the approval of a phase 2b/3 adaptive design pivotal trial intended to further evaluate the efficacy and safety of SYN-010.
SYN-010 is a proprietary, modified-release formulation of lovastatin lactone 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. Methane produced by M. smithii has been correlated with bloating, pain and constipation associated with 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.