Synthetic Biologics announces encouraging clinical trial results for IBS patients
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.
Organizations in this story
Synthetic Biologics, Inc. 9605 Medical Center Dr Rockville, MD 20850-2959