US-based Synthetic Biologics has started the second Phase II clinical trial of its proprietary SYN-010 to treat irritable bowel syndrome with constipation (IBS-C).
The multi-centre, open-label trial is designed to evaluate the sustainability of the effect of one dose strength of SYN-010 on breath methane production in breath methane-positive patients with IBS-C.
The trial will also assess major clinical outcomes, including frequency of complete spontaneous bowel movements (CSBM), abdominal pain and bloating.
In IBS-C patients, the presence of breath methane has been associated with pain, bloating and constipation.
In North America, IBS affects an estimated 10% to 15% of the population, or as many as 45 million people.
Both men and women are affected by this illness, while two-thirds of diagnosed sufferers are women.
The company noted that the existing FDA-approved therapies to treat IBS-C and other treatments, including prescription and over-the-counter (OTC) laxatives, provide patients with temporary symptomatic relief, but do not treat the underlying cause of pain, bloating and constipation associated with IBS-C.
Synthetic Biologics chief executive officer Jeffrey Riley said: "Synthetic Biologics' IBS-C programme is moving through the clinic as planned. Patient enrolment in the first Phase II clinical trial of SYN-010 is complete and all patients have received their first dose according to the randomization protocol.
"As the patients complete the first Phase II clinical trial, they are eligible to immediately rollover into the second Phase II 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 CSBM, 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."
The second Phase II trial is being conducted at multiple centres in the US and its primary objective is to evaluate the sustainability of the effect of one dose strength of SYN-010 on breath methane production in breath methane-positive patients with IBS-C.
The trial's secondary objectives include evaluating the reduction in abdominal pain and bloating, and the increase in CSBM.
Approximately 60 patients, who complete the first Phase II clinical trial of SYN-010, are eligible to immediately rollover into the second Phase II trial of SYN-010.
In this trial, patients are scheduled to receive a single oral dose of SYN-010 each day for two months.
Riley said: "At this time, more than half of the total participants have completed the first Phase II clinical trial and rolled over into the second Phase II clinical trial of SYN-010.
"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 II clinical trial during the first half of 2016."
SYN-010 is a modified-release formulation of the classic statin, lovastatin, that is intended to reduce methane production by certain microorganisms (M smithii) in the gut, while minimising disruption to the microbiome.
The company noted that methane produced by M smithii is perceived as the underlying cause of pain, bloating, and constipation associated with IBS-C.