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Microbiome-based therapy meets primary endpoint in phase 2 trial of patients with IBS-C
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SYN-010, a microbiome-based therapy in development for patients with irritable bowel syndrome with constipation, significantly reduced methane production and improved other symptoms in its second phase 2 clinical trial, the manufacturer announced.
SYN-010 (Synthetic Biologics) is a modified-release formulation of lovastatin lactone that aims to treat an underlying cause of IBS-C by decreasing methane produced by the gut microbe Methanobrevibacter smithii with minimal disturbance of the microbiome, according to a press release. It is intended to act mainly in the intestinal lumen and avoid being absorbed systemically to target a main underlying cause of IBS-C rather than treating symptoms alone.
Mark Pimentel
“These topline data demonstrate the positive effect of SYN-010 on decreasing gut methane production, abdominal pain and bloating, and improving stool frequency and quality of life scores in IBS-C patients who are breath-methane positive,” Mark Pimentel, MD, director of the GI Motility Program and Laboratory at Cedars-Sinai, and chairman of Synthetic Biologics’ IBS-C Clinical Advisory Board, said in a press release. “Current IBS-C treatments are focused on relieving symptoms. These latest SYN-010 findings, along with previously reported topline data, strongly suggest a potential role for SYN-010 in treating a major underlying cause of IBS-C by reducing the production of methane in the gut, versus relieving symptoms.”
The 8-week, multicenter, open-label extension study involved 54 patients who were rolled over from the first phase 2 trial of SYN-010. The extension study aimed to assess the sustainability of reductions in breath methane achieved with 42 mg daily in IBS-C patients with positive breath methane. Reductions in abdominal pain and bloating, and improved stool frequency and quality of life served as secondary endpoints.
Over 12 weeks of total treatment spanning the first and second trials, methane production decreased significantly (P = .002) as did the mean IBS Symptom Severity Score (P < .0001). Moreover, the proportion of patients identified as monthly responders, “an FDA-defined composite measure incorporating improvements in complete spontaneous bowel movements … and abdominal pain,” also increased.
“Meeting the study endpoints and demonstrating positive clinical outcomes in this phase 2 trial of SYN-010 bring us closer to offering a therapeutic to the millions of people who suffer from IBS-C,” Jeffrey Riley, CEO of Synthetic Biologics, said in the press release. “During the first half of 2016, we anticipate reporting detailed results from this phase 2 clinical trial and requesting an end of phase 2 meeting with the FDA. Concurrent with the analysis of the phase 2 data, we are actively planning the phase 3 program for SYN-010.”