GI Dynamics Press Release - January 15, 2013
GI Dynamics, Inc. Initiates U.S. Pivotal Clinical Trial of EndoBarrier®
LEXINGTON, Mass. & SYDNEY -- Jan. 15, 2013 -- GI Dynamics, Inc. (ASX: GID) today announced that it has initiated its U.S. multicenter pivotal clinical trial of EndoBarrier®, the ENDO Trial, for the treatment of patients who have uncontrolled type 2 diabetes and are obese.
EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. In previous clinical studies, EndoBarrier has been shown to achieve rapid reductions in blood sugar levels and weight loss of approximately 20 percent in 12 months., EndoBarrier received CE Mark approval in 2010, and approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity for up to 12 months.
“We’re excited to initiate this important trial in the U.S.,” said Lee M. Kaplan, M.D., Ph.D., lead investigator and director of the Obesity, Metabolism & Nutrition Institute at the Massachusetts General Hospital and Harvard Medical School. “Results from the pilot studies of EndoBarrier have been very promising, and we look forward to determining the efficacy and safety of this device in this large, controlled, pivotal trial.”
People interested in learning more about the ENDO Trial should visit www.endobarriertrial.com or call 1-888-9STUDY9 (1-888-978-8399).
“The start of our U.S. pivotal trial marks a major milestone on the road to bringing EndoBarrier to the millions of people in this country living with type 2 diabetes,” said Stuart A. Randle, president and chief executive officer, GI Dynamics. “We appreciate the support of our investigators and clinical trial sites as we begin the process of enrolling patients and executing this landmark clinical trial.”
EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. In 12 clinical studies conducted outside the United States and one conducted in the United States, with more than 500 patients, EndoBarrier has been tested in similar patient populations. EndoBarrier received CE Mark approval in 2010, and approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity for up to 12 months. EndoBarrier is now pursuing commercial status in the United States. The first step in this process is a successful completion of the ENDO Trial. The device was developed by GI Dynamics, Inc., based in Lexington, Mass. More information about the company may be found at www.gidynamics.com.
About the ENDO Trial
The ENDO Trial is a randomized, double-blind, sham controlled, multi-center trial that is expected to enroll approximately 500 people living with uncontrolled diabetes and obesity who meet specific enrollment criteria at up to 25 sites in the United States. The trial is designed to assess improvements in diabetes over a treatment period of up to 12 months. The primary endpoint of the trial is improvement in HbA1c (a key blood sugar measure for diabetes); secondary measures include weight loss and improvement in select cardiovascular risk factors, such as cholesterol.
About Type 2 Diabetes and Obesity
Estimates indicate that type 2 diabetes affects more than 23 million people in the United States, and approximately 320 million people worldwide. Type 2 diabetes, which accounts for approximately 90 percent of all cases of diabetes, occurs when the pancreas has reduced effectiveness in insulin production associated with an increase in insulin resistance. The diagnosis of type 2 diabetes usually occurs after the age of 40 and is often, but not always, associated with obesity.
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. 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 enrollment 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.
 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.
 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.
 Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011.
 International Diabetes Federation, 5th edition of the Diabetes Atlas, 2011