Synthetic Biologics, Inc., a clinical stage company focused on developing therapeutics to protect the gut microbiome, announced that the US Patent and Trademark Office (USPTO) issued a Notice of Allowance for a patent application which covers the use of a variety of compounds, including the active agent of SYN-010, the company's proprietary, modified-release formulation of lovastatin lactone designed to treat a major underlying cause of irritable bowel syndrome with constipation (IBS-C).
US Patent Application No. 14/211,197 also includes claims that provide protection for proprietary patient screening technology developed by Mark Pimentel, M.D., FRCP(C), director of Cedars-Sinai Medical Center (CSMC)'s GI Motility Program and Laboratory and Chairman of Synthetic Biologics' IBS-C Clinical Advisory Board. Upon issuance, this patent, which is owned by CSMC and exclusively licensed to Synthetic Biologics, strengthens the company's extensive SYN-010-related patent estate and extends the term of the Company's patent protection to at least 2034.
In November 2015, the USPTO issued the first US patent directly pertaining to the use of SYN-010. The issuance of this new patent, which is also owned by CSMC and exclusively licensed to Synthetic Biologics, expands the SYN-010 intellectual property portfolio to approximately 55 issued US and foreign patents. In addition, there are approximately 15 US and foreign patents pending, which upon issuance will further strengthen the intellectual property position surrounding SYN-010.
"The allowance of this patent in conjunction with our recent announcement of positive topline data from the phase 2 clinical trials of SYN-010, demonstrates the progress we have made toward our goal of bringing this important therapy to IBS-C patients," said Jeffrey Riley, president and chief executive officer of Synthetic Biologics. "As we plan for an end of phase 2 meeting with the FDA and to initiate Phase 3 clinical trials during 2016, we look forward to building long-term value for our shareholders."
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 is perceived as an underlying cause of 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.