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Synthetic Biologics receives U.S. patent for microbiome-based drug candidate for IBS-C

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The U.S. Patent and Trademark Office has issued a patent to Synthetic Biologics covering the active agent in SYN-010, the company’s novel microbiome-based drug candidate for the treatment of constipation-predominant irritable bowel syndrome, according to a press release.

“This new patent will strengthen the protection of SYN-010 in the U.S. and complements existing foreign patents,” Jeffrey Riley, CEO of Synthetic Biologics, said in the press release. “We continue to bolster the company’s patent estate while making progress toward our goals to report phase 2 topline results from both our IBS-C and prevention of C. difficile infection programs this quarter.”

Mark Pimentel



The patent was issued on November 24, and is the first U.S. patent issued to the company which directly pertains to SYN-010, according to the press release. It is exclusively licensed from Cedars-Sinai Medical Center, and results from research efforts led by Mark Pimentel, MD, FRCP, director of Cedars-Sinai Medical Center’s GI Motility Program and Laboratory, and Synthetic Biologics’ IBS-C clinical advisory board chairman. Similar patents have already been issued in Europe, Canada and Australia, and additional patent filings could extend protection of SYN-010 to 2035.

SYN-010 is a modified-release formulation of lovastatin lactone designed to decrease methane production by Methanobrevibacter smithii in the gut with minimal impact to the gut microbiome, according to the press release. It is “intended to act primarily in the intestinal lumen, ideally limited systemic absorption, thereby targeting a major cause of IBS-C, not just the symptoms.”

The company expects a 505(b)(2) regulatory pathway for the drug, according to the press release.

Disclosures: Riley and Pimentel report they are both affiliated with Synthetic Biologics.