LEXINGTON, Mass. & AMSTERDAM--(GI Dynamics, Inc. (ASX: GID) today announced the first study evaluating the long-term benefits and safety of re-implanting EndoBarrier® to extend weight loss benefits for three years. Data suggest EndoBarrier may be re-implanted approximately one year after completion of the initial treatment period, which may help obese people experience additional weight loss, long-term weight loss maintenance and improvement in other co-morbid conditions, including cholesterol, blood pressure and fasting blood glucose (FPG), a key measure of blood sugar levels used to diagnose diabetes.)--
“Post-explant follow-up after 12 months implantation of an endoscopic duodenal-jejunal bypass liner.”
The study findings, which were presented during the 20th United European Gastroenterology Week (UEGW), support earlier evidence that EndoBarrier provides sustained weight loss and glycemic control benefits long after its removal, and suggest that these benefits can be extended and improved by repeating EndoBarrier Therapy for an additional year.
“We had demonstrated in a prior study that EndoBarrier could safely be re-implanted in patients previously treated for one year,” said Alex Escalona, M.D., Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile. “We are very pleased to see the data from this study which builds on our feasibility study and indicates that patients who have successfully completed an initial course of EndoBarrier Therapy can not only maintain a majority of their weight loss during the interim treatment period, but can also achieve additional weight loss and metabolic benefits with a second round of EndoBarrier Therapy.”
These data were presented in a poster titled, “One year follow-up after re-implantation of the endoscopic duodenal-jejunal bypass liner.” For this study, 24 obese patients, who were previously implanted with EndoBarrier for one year and who completed at least 31 weeks of follow-up post EndoBarrier removal, were invited to participate. Of these, 19 patients were re-implanted with EndoBarrier and 14 completed a second year of EndoBarrier Therapy. Among these patients, key treatment results observed from baseline to re-explant of EndoBarrier included:
- Total body weight loss of 22.6 kg (p<0.0001);
- Decrease in body mass index (BMI) from 43.8 ± 5.9 to 33.5 ± 5.2 (p<0.0001);
- Total reduction in triglyceride levels of 55.7 (p<0.118);
- Decrease in FPG from a mean of 106.6 ± 5.2, a diagnosis of prediabetes according to the American Diabetes Association (ADA), to a mean of 93.4 ± 21.3, a reading the ADA considers to be within the normal range (p<0.034);
- No procedure-related complications associated with re-implantation
Stuart A. Randle, president and chief executive officer of GI Dynamics, Inc., stated, “EndoBarrier Therapy has already been proven to be effective in treating type 2 diabetes and obesity for one year, with sustained benefits observed for up to 12 months following explant. This re-implantation data expands our current understanding by demonstrating that the overall health benefits of initial EndoBarrier Therapy can be safely extended and improved following a second treatment period.”
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.
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.
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.