Synthetic Biologics Inc., a Michigan and Maryland-based clinical stage company developing therapeutic IBS treatment, recently revealed that its second Phase II SYN-010 clinical trial for irritable bowel syndrome with constipation (IBS-C) has met its primary endpoint.
Data from phase II clinical trial patients revealed a noteworthy decrease in methane production over time with no adverse effects, in addition to improvement in severity level — measured by the symptoms of abdominal pain, bloating, stool frequency and quality-of-life assessment scores — and unassisted bowel movements.
"These top-line 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," Dr. Mark Pimentel, clinical advisory board chairman for Synthetic Biologics' IBS-C division, said.
Synthetic Biologics CEO Jeffrey Riley noted that meeting the study endpoints and showing positive outcomes bring the company closer to implementing Phase III for SYN-10.
The second Phase II study ran for eight weeks in multiple U.S. facilities, with the top priority of assessing the effect of one daily 42-milligram dose of SYN-10 on breath methane-positive patients with IBS-C. Additional goals included reducing abdominal pain and bloating, as well as improving stool frequency and life quality.
"Current IBS-C treatments are focused on relieving symptoms," Pimentel said. "These latest SYN-010 findings, along with previously reported top-line 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."
Synthetic Biologics' principal executive offices are located in Rockville, Maryland, with finance and administrative offices in Ann Arbor, Michigan.
