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Mechanism of action

EndoBarrier induces changes in bile acids levels

Data show increased levels of bile acids following treatment with Endobarrier

EndoBarrier induces significant changes in the level of bile acids (BAs), according to the latest data from a joint study between GI Dynamics and GlaxoSmithKline (GSK) into EndoBarrier and its potential mechanism of action. Presented at Digestive Disease Week 2014 during an oral presentation titled, ‘Duodenal-jejunal Bypass Liner Increases Fasting and Postprandial Serum Levels of Bile Acids in Patients with Severe Obesity’, the study is the result of an agreement between the companies signed in January 2013 to investigate the mechanism of action of the EndoBarrier and related hormonal and metabolic changes.

Researchers have proposed that increased postoperative levels of 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).

“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,” said Dr David Maggs, chief medical officer, GI Dynamics. “This mechanism may be the driver of the significant weight loss and glucose stabilisation seen in patients treated with EndoBarrier.”

“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,” added 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.”

The company has also raised approximately AUS$34.3 million in its latest financing round, which it intends to fund its US pivotal trial, to expand commercialisation efforts for EndoBarrier Therapy, and for general working capital purposes.

“We are very pleased with the successful completion of this financing,” said Stuart A Randle, president and CEO of GI Dynamics. “This financing provides additional resources to support our ongoing pivotal trial in the US. This capital also allows us to continue to execute on our global dual-pronged commercial strategy focused on driving sales in the near term in self-pay markets, while building for the long-term success and future growth of EndoBarrier Therapy in reimbursed markets.”

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