New patent to cover treatment for IBS-C

Mark Pimentel

The U.S. Patent and Trademark Office issued allowance of a patent application covering SYN-010, a modified formulation of lovastatin lactone, created by Synthetic Biologics Inc., for the treatment of irritable bowel syndrome with constipation until at least 2034, according to a press release.

The allowance of this patent, owned by Cedars-Sinai Medical Center (CSMC), expands the SYN-010 intellectual property portfolio to about 55 issued U.S. and foreign patents, with more patents pending whose issuance may further strengthen the position surrounding SYN-010.

The researchers, including Mark Pimentel, MD, FRCP(C), program director of CSMC’s medically associated science and technology program and chairman of Synthetic Biologic’s IBS-C clinical advisory board, focused on research that associates methane production in the gut by certain microorganisms with common symptoms of IBS-C.

Results from a phase 2 clinical trial conducted by Synthetic Biologics showed that SYN-010 significantly decreased abdominal pain and bloating, and improved stool frequency and quality of life scores in patients with IBS-C without causing severe adverse events. Further, a phase 2b/3 adaptive design pivotal trial to assess the efficacy and safety of SYN-010 has been approved by the FDA.

“Once issued, this patent will extend the protection around the use of SYN-010 to treat IBS-C by an additional 11 years and significantly strengthens the opportunity to build long-term value for our shareholders,” Jeffrey Riley, MBA, MIM, president and CEO of Synthetic Biologics, said in the release. “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.”

Disclosure: Riley is president and CEO of Synthetic Biologics, and Pimentel serves on the advisory board.