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Second Phase 2 Trial of Microbiome-based Therapeutic for IBS-C Initiated
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The second phase 2 clinical trial of SYN-010 for the treatment of constipation-predominant irritable bowel syndrome has been initiated, the manufacturer announced.
SYN-010 (Synthetic Biologics) is a modified-release formulation of lovastatin designed to treat constipation-predominant IBS (IBS-C) by reducing methane production by M. smithii microbes in the gut while minimizing microbiome disruption, according to the press release. Higher intestinal methane production has been linked to pain, bloating and constipation in IBS-C patients. The drug is intended to target the intestinal lumen and avoid systemic absorption.
“Synthetic Biologics’ IBS-C program is moving through the clinic as planned. Patient enrollment in the first phase 2 clinical trial of SYN-010 is complete and all patients have received their first dose according to the randomization protocol,” Jeffrey Riley, CEO of Synthetic Biologics, said in a press release. “As the patients complete the first phase 2 clinical trial, they are eligible to immediately roll over into the second phase 2 clinical trial of SYN-010 that will evaluate the ability of SYN-010 to sustain the reduction in breath methane levels, and the frequency of [complete spontaneous bowel movements], abdominal pain and bloating. Current treatments are focused on relieving symptoms, whereas SYN-010 has therapeutic potential to reduce the production of methane in the gut, treating a major underlying cause of IBS-C.”
This U.S. multicenter, open-label study aims to determine whether the effect of a once-daily, single oral dose of SYN-010 on breath methane production is durable in IBS-C patients who are breath-methane positive, according to the press release. The treatment period will last approximately 2 months, and the study will also evaluate frequency of complete spontaneous bowel movements, abdominal pain and bloating. About 60 patients from the first trial are eligible for immediate enrollment in the second.
“At this time, more than half of the total participants have completed the first phase 2 clinical trial and rolled over into the second phase 2 clinical trial of SYN-010,” Riley said in the press release. “We continue to anticipate reporting topline results from the first phase 2 clinical trial of SYN-010 during the fourth quarter of 2015, and reporting topline results from the second phase 2 clinical trial during the first half of 2016.”
Disclosures: Riley reports he is an employee of Synthetic Biologics.