LEXINGTON, Mass., & SYDNEY--(BUSINESS WIRE)--GI Dynamics, Inc. (ASX: GID) announced today that clinical data about EndoBarrier® Therapy, a breakthrough treatment for type 2 diabetes and/or obesity, was presented at the 29th Annual Meeting of the American Society for Metabolic & Bariatric Surgery (ASMBS) in San Diego. ASMBS is the largest organization for bariatric surgeons in the world. Interim data was previously presented at the 2012 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Postgraduate Course.
During a plenary session on “Emerging Technologies and Concepts,” Ricardo V. Cohen, M.D., Center for the Surgical Treatment of Morbid Obesity and Metabolic Disorders, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil, presented findings from his study, “Metabolic Improvement in Type 2 Diabetes in Subjects without Severe Obesity with the Endoscopic Duodenal-Jejunal Bypass Liner.”
This non-randomized, single-arm, single-center study evaluated EndoBarrier Therapy in 20 patients with uncontrolled type 2 diabetes and a mean body mass index (BMI) of 30.0 kg/m2 (range: 23-36) over a one-year period. Sixteen patients completed one year of EndoBarrier Therapy with the following results:
- A statically significant mean decrease in HbA1c of 1.1% (from 8.6% at baseline to 7.5%) (p<0.05)
- HbA1c levels ≤7.0% in 62.5% of the patients
- A statically significant decrease in total body weight loss of 9.4% (p<0.05)
- Statically significant reductions in total cholesterol (from 218 mg/dL at baseline to 189 mg/dL)(p<0.05) and LDL (from 135 mg/dL at baseline to 111 mg/dL) (p< 0.05)
“Our data point to a substantial improvement in glycemic control and other metabolic parameters even among overweight – but not severely obese – diabetic patients during EndoBarrier Therapy,” remarked Dr. Cohen. “These are promising data and suggest that EndoBarrier may play a valuable role for overweight patients struggling to control their diabetes and lose weight.”
“As one of the earliest researchers of EndoBarrier Therapy, Dr. Cohen has contributed greatly to the aggregate of clinical data supporting the efficacy of our technology in improving type 2 diabetes and weight loss,” said Mark C. Twyman, chief commercial officer, GI Dynamics, Inc. “The population in this particular study had a BMI lower than any previous EndoBarrier study; and even so, EndoBarrier Therapy produced meaningful and clinically significant benefits with regard to glycemic control, weight loss and other metabolic parameters.”
About EndoBarrier
EndoBarrier Therapy is a breakthrough treatment for type 2 diabetes and/or obesity that has been clinically demonstrated to lower HbA1c levels, achieve weight loss of more than 20 percent within a year, and improve important metabolic measures including cholesterol, blood pressure and triglycerides.1,2 It has been studied in 13 clinical trials and used in more than 500 patients. The EndoBarrier device is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. EndoBarrier Therapy affects certain gastrointestinal hormones involved in insulin sensitivity, glucose metabolism and satiety, and these changes allow for rapid and sustained improvement of type 2 diabetes and weight loss.3
EndoBarrier received CE Mark approval for Europe in 2010 as well as approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity. EndoBarrier is currently commercially available in select European markets, Chile and Australia. 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 European countries. 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; 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.
3 C de Jonge, JW Greve, N Bouvy, et al, EndoBarrier Gastrointestinal Liner treatment rapidly improves diabetes parameters paralleled by increased postprandial GLP-1 and PYY levels in obese type 2 diabetic patients, Department of Surgery, Maastricht University Medical Centre, presented at IFSO 2011, Hamburg, Germany.