GI Dynamics Announces New Insights into EndoBarrier® Therapy’s Influence on Key Hormones Affecting Satiety and Blood Sugar Control

AMSTERDAM & LEXINGTON, Mass.--(BUSINESS WIRE)--GI Dynamics, Inc. (ASX: GID) today announced data, presented during the 20^th United European Gastroenterology Week (UEGW), which adds to the growing body of clinical and preclinical evidence of the influence EndoBarrier^® Therapy may have on key intestinal hormones that control appetite and glucose metabolism. GI Dynamics and several of its collaborators have now shown in animal models and clinical studies that much like gastric bypass surgery, EndoBarrier Therapy affects critical metabolic hormones, including the gut peptides glucagon-like peptide-1 (GLP-1), gastric inhibitory peptide (GIP) and peptide YY (PYY), as well as insulin, glucagon, ghrelin and leptin.

“These results suggest that it is the intestinal manipulation – duodenal exclusion and accelerated increased delivery of nutrients to the distal small intestine – rather than gastric modification, that contributes most significantly to increased energy expenditure which contributes to weight loss”

“Our understanding of the mechanisms by which EndoBarrier Therapy helps patients achieve their desired diabetes control and weight loss results is growing,” said Stuart A. Randle, president and chief executive officer of GI Dynamics, Inc. “These data suggest that EndoBarrier Therapy mimics the way gastric bypass manipulates hormonal signals in the small intestine to lower blood sugar, induce appetite reduction and lower caloric intake. Importantly, unlike gastric bypass, EndoBarrier Therapy does not require surgery and has the potential to redefine how we approach the treatment of type 2 diabetes and obesity.”

Mechanisms of Diabetes & Obesity Control: Clinical Data

A poster titled, “The impact of the EndoBarrier on body weight and satiety hormones,” was presented at UEGW today. In the study, EndoBarrier was implanted in 17 obese patients with type 2 diabetes and researchers measured weight loss, satiety and changes in plasma levels of GLP-1, PYY, ghrelin and leptin. Data observed at 24 weeks from baseline show:

• Weight loss of 12.7± 1.3 kg and 29.8 ± 3.5 percent reduction in excess weight
• Increased satiety in 15 out of 17 patients and reduced caloric intake in all patients
• Rise in the levels of ghrelin, an appetite-regulating hormone
• Decrease in levels of leptin, a hormone linked to appetite regulation, fat metabolism and blood sugar control

These data complement previously reported diabetes-related results from the same study presented at the 2011 European Association for the Study of Diabetes (EASD):

• Rapid and sustained increase in insulin sensitivity and/or decreased endogenous glucose production
• Increased levels of both PYY and GLP-1 one-week post-placement
• Reduction in mean HbA_1c levels of 1.4 percent (from 8.4 percent at baseline to 7.0 percent)
• Normalization of glucagon response
• Reduction in use of anti-diabetic medications in 16 out of 17 participants

“In this study, we were able to show the glucose management and appetite control effects of EndoBarrier Therapy at the metabolic level, where we observed measurable fluctuations in the secretion of key hormones instrumental to weight loss and glucose homeostasis,” said the study’s lead investigator, Charlotte de Jonge, M.D., Maastricht University Medical Centre, The Netherlands. “Our results reinforce that EndoBarrier Therapy controls satiety, food intake, and blood glucose levels via endocrine pathways to successfully treat type 2 diabetes and yield important weight loss benefits.”

Mechanisms of Diabetes & Obesity Control: Preclinical Study

These clinical data, combined with recently published data in the September 2012 issue of the American Journal of Physiology – Regulatory, Integrative and Comparative Physiology, further elucidate the mechanism of action behind the weight loss and glycemic control benefits of EndoBarrier Therapy. The newly published preclinical data demonstrate that obese rats implanted with EndoBarrier exhibited enhanced GLP-1 secretion and improved glucose tolerance and insulin sensitivity out of proportion to the effects of weight loss alone. The study concluded that by creating a physical barrier between ingested nutrients and the proximal small intestinal wall, EndoBarrier influences neuroendocrine signals to normalize the physiological regulation of energy balance and glucose homeostasis.

“These results suggest that it is the intestinal manipulation – duodenal exclusion and accelerated increased delivery of nutrients to the distal small intestine – rather than gastric modification, that contributes most significantly to increased energy expenditure which contributes to weight loss,” stated Lee M. Kaplan, M.D., Ph.D., senior author of the study and director of the Obesity, Metabolism & Nutrition Institute at the Massachusetts General Hospital and Harvard Medical School. “This study also expands our understanding of the contribution of duodenal nutrient exclusion to improved glucose homeostasis and establishes a valuable therapeutic strategy for treating people suffering from type 2 diabetes and obesity.”

EndoBarrier Therapy is a non-surgical, non-pharmaceutical treatment for type 2 diabetes and/or obesity. EndoBarrier is placed in the intestine during a brief, endoscopic procedure and acts as a physical barrier between food and the intestinal wall.

EndoBarrier Therapy is currently available in select countries in Europe, including The Netherlands, Austria, Germany and the United Kingdom, as well as Australia and Chile. In August, GI Dynamics also received conditional approval from the U.S. Food and Drug Administration to commence a pivotal clinical trial of EndoBarrier in the United States for the treatment of patients who have uncontrolled type 2 diabetes and are obese.

About EndoBarrier

EndoBarrier Therapy is a revolutionary, non-surgical, non-pharmaceutical treatment for people with type 2 diabetes and/or obesity. Clinical studies demonstrate that EndoBarrier Therapy achieves rapid and dramatic reductions in blood sugar levels, improvement of cardiovascular risk factors including blood pressure, cholesterol and triglycerides,^1,2 and weight loss of approximately 20 percent in 12 months. EndoBarrier Therapy is an effective, convenient and discreet treatment for people whose diabetes medications are no longer effective, who are at risk for serious health complications and who want to avoid the progression to daily insulin injections. Involving a brief endoscopic procedure, EndoBarrier Therapy also enables patients to avoid the lifestyle changes and frequent post-surgical interventions associated with irreversible bypass surgery and gastric banding. This first-of-its-kind therapy is helping patients around the world fight their battle against type 2 diabetes and obesity while providing a pathway to a healthier lifestyle. For more information, please visit www.EndoBarrier.com.

About GI Dynamics

GI Dynamics, Inc. (ASX: GID) is pioneering the development and commercialization of effective, non-surgical treatments targeting the large and growing global patient populations with type 2 diabetes and obesity. The company’s flagship product, EndoBarrier®, is a novel, non-surgical device proven to lower blood glucose levels and promote weight loss in diabetic patients and/or obese patients during the implant period. GI Dynamics currently markets EndoBarrier in select regions in Europe, South America and Australia and is planning near-term commercial expansion into additional markets. The EndoBarrier is not approved for sale in the United States and is considered investigational. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit www.gidynamics.com.

Forward-Looking Statements

This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to commercialize our EndoBarrier® including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products including our ability to obtain reimbursement for our products; our expectations with respect to our clinical trials, including enrolment in or completion of our clinical trials and our associated regulatory submissions and approvals; and our expectations with respect to the integrity or capabilities of our intellectual property position. Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. GI Dynamics does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. GI Dynamics may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, described in “Risk Factors” in our Prospectus lodged with the Australian Securities & Investments Commission on 3 August 2011.

¹ Moura, GHD, et al, One Year Results of an Endoscopic, Duodenal-Jejunal Exclusion Device for Weight Loss and Control of Type 2 Diabetes. Hospital das Clinicas, University of São Paulo, São Paulo, Brazil. DT&T, February 2012, vol 14, no.2:183-189.

² Escalona, A., et al, “Post-explant follow-up after 12 months implantation of an endoscopic duodenal-jejunal bypass liner.” Department of Digestive Surgery. Faculty of Medicine Pontificia Universidad Católica de Chile. Annals of Surgery, June 2012, Vol 255, Issue 6, p 1080–1085.