Synthetic Biologics Inc., a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, announced that researchers at Cedars-Sinai Medical Center found that eradication of breath methane and reduction of intestinal levels of the most common methanogenic bacterium in the human gut (M. smithii) resulted in improved insulin sensitivity by up to 50%, and a reduction in total cholesterol and LDL cholesterol levels in pre-diabetic, obese human subjects. The findings provide preliminary evidence that the management of methane in the gut may lead to a new generation of medicines for treating Type 2 diabetes and obesity, two morbidities often linked together.
This Cedars-Sinai study, which was funded by the American Diabetes Association (ADA), was the subject of a late breaking poster presentation at the ADA's 74th Scientific Sessions recently held in San Francisco. This research examined the effects of methane-regulating treatments on conditions such as Type 2 diabetes and obesity, which along with constipation-predominant irritable bowel syndrome (C-IBS), are the three conditions for which Synthetic Biologics has the right to develop treatments under the exclusive license agreement with Cedars-Sinai dated December 5, 2013. The most clinically advanced of Synthetic Biologics' programs in this area is the development of SYN-010, an oral treatment to reduce the impact of methane producing organisms on C-IBS, with a Phase 2 trial expected to start during the second half of 2014.
In the poster presented at ADA, lead researcher Ruchi Mathur, M.D., FRCP(C) of Cedars-Sinai, along with other Cedars-Sinai researchers, including Mark Pimentel, M.D., FRCP(C), reported that eradication of M. smithii (as measured by the surrogate of breath methane) in 8 of the 11 pre-diabetic, obese subjects tested resulted in improvement in the subjects' metabolic profiles after a 10 day course of antibiotics.
"Cedars-Sinai researchers have previously shown that the presence of methane in the gut is associated with a slowing of intestinal transit, which may also allow for increased time for absorption of nutrients and enhanced energy harvest thus contributing to a variety of diseases including C-IBS, diabetes and obesity," noted Jeffrey Riley, chief executive officer of Synthetic Biologics.
Riley concluded, "The results from this new research provide further exciting insight into the role of gut methane in various metabolic diseases, including Type 2 diabetes and obesity. These findings also support Synthetic Biologics' efforts to develop new therapeutic agents, such as SYN-010, to manage the chronic symptoms of C-IBS through gut methane depletion."
Date: June 25, 2014
Source: Synthetic Biologics