Remember EndoBarrier® from GI Dynamics, Inc., the endoscopically insertable sleeve that aims to address type 2 diabetes and obesity? The company has announced that new data from a study performed with GlaxoSmithKline has been presented at Digestive Disease Week 2014 (DDW) during an oral presentation titled, “Duodenal-jejunal Bypass Liner Increases Fasting and Postprandial Serum Levels of Bile Acids in Patients with Severe Obesity.”potential mechanism of action were presented at
Background
EndoBarrier is a flexible, tube-shaped liner that is inserted endoscopically and placed at the beginning of the small intestine, where it remains for up to one year, after which it is removed during another endoscopic procedure. EndoBarrier has been approved in select countries internationally since 2010 and is available in Chile, Australia and a growing number of countries in Europe and the Middle East. It is currently under investigation in the U.S. as part of a multicenter, pivotal clinical trial (The ENDO Trial) for the treatment of patients who have uncontrolled type 2 diabetes and are obese.
Researchers have proposed that increased postoperative levels of bile acids (BAs) may be tied to the effectiveness of a common type of gastric bypass surgery, Roux-en-Y gastric bypass (RYGB).
To better understand the method of action of the EndoBarrier and how it may mimic RYGB, the study authors evaluated BA levels in 17 patients with severe obesity, with and without type 2 diabetes. Findings show that after 52 weeks of treatment with EndoBarrier, a 16% total body weight loss was accompanied by fasting total BAs levels over two-fold higher than those observed at baseline (1.3±0.3 vs 3±0.5 μMol/L, p<0.05); and following a standard test meal, nutrient-stimulated levels of total BAs were also increased by 70% (475vs805 AU, p<0.05).
Company comments
for GI Dynamics
“Early last year we formed an association with GSK to better understand the mechanism of action of the EndoBarrier and related hormonal and metabolic changes,” stated David Maggs, M.D., chief medical officer, GI Dynamics, Inc. “The increased level of bile acids we observed suggest that there may be a similar mechanism of action associated with EndoBarrier in the treatment of obesity and diabetes to that observed with gastric bypass. This mechanism may be the driver of the significant weight loss and glucose stabilization seen in patients treated with EndoBarrier.”
for GSK
“These findings show that EndoBarrier induced significant changes in the level of bile acids, which play a known role in the regulation of energy and glucose homeostasis,” stated Andrew Young, vice-president and head of endocrine biology, GlaxoSmithKline. “Although further exploration is needed, these data offer the beginning of a mechanistic explanation for the robust effects on body weight seen with EndoBarrier and support the continued investigation of EndoBarrier in patients with type 2 diabetes and obesity.”
Source: GI Dynamics, Inc., Business Wire
published: May 5, 2014 in: Clinical Studies/Trials, Congresses and Meetings, Gastroenterology