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Clinical trial underway for microbiome-based therapy for IBS-C

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A phase 2 clinical trial of SYN-010 for the treatment of irritable bowel syndrome with constipation has been initiated, the manufacturer announced.

“With up to 9 million people suffering from IBS-C in the U.S., the development of SYN-010 [Synthetic Biologics] has an opportunity to address a significant unmet medical need,” Mark Pimentel, MD, FRCP, director of the GI Motility Program and Laboratory at Cedars-Sinai in Los Angeles, said in a press release. “Current treatments are focused on relieving symptoms, whereas SYN-010 has therapeutic potential to diminish the production of methane in the gut, treating a major cause of IBS-C, not just the symptoms.”

Mark Pimentel

SYN-010 is a modified-release formulation of lovastatin intended to reduce the methane production of the gut microbe M. smithii while protecting the microbiome from being disrupted, according to the release. SYN-010 is intended to target the intestinal lumen and avoid being absorbed systemically.

The current randomized, double-blind, parallel-group, placebo-controlled, multi-dose study aims to determine changes in breath methane after 7 days of SYN-010 treatment with one of two dose formulations or placebo, the release said. Multiple U.S. centers are expected to participate, and an estimated 60 patients are expected to be enrolled.

“Initiating this phase 2 clinical trial is an important first step to moving Synthetic Biologics' IBS-C program through the clinic,” Jeffrey Riley, CEO of Synthetic Biologics, said in a press release. “Patients who complete this first phase 2 clinical trial of SYN-010, may enroll in a second, SYN-010 only, phase 2 extension clinical trial that will evaluate the ability of SYN-010 to sustain the reduction in breath methane levels. We anticipate initiating the second phase 2 trial and reporting topline results from the first phase 2 clinical trial during the second half of 2015.”

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