Accumulated Clinical Experience across Four International Studies Highlighted in Two Presentations at World IDF Congress
LEXINGTON, Massachusetts & MELBOURNE, Australia – 3 December 2013 – GI Dynamics, Inc. (ASX: GID) today announced findings from a new meta-analysis which describes the increasingly robust efficacy and safety profile of EndoBarrier® Therapy, an endoscopically-delivered device therapy approved for the treatment of type 2 diabetes and obesity. The findings, which were presented today at the International Diabetes Federation’s World Diabetes Congress in Melbourne, Australia, add to the growing body of clinical evidence supporting the use of EndoBarrier Therapy for patients with type 2 diabetes and obesity.
“The progressive nature of type 2 diabetes and obesity poses a significant and growing challenge in clinical practice, and current therapies often do not provide optimal solutions for many patients,” said David Maggs, chief medical officer of GI Dynamics, and lead author of the study. “Medical devices such as EndoBarrier represent an exciting class of therapy that can help bridge the gap between pharmaceuticals, which may become less effective over time, and bariatric surgery, which can be effective, however, requires irreversible anatomical changes. These new meta-analysis data further support the strong safety profile and robust efficacy of EndoBarrier Therapy in the management of type 2 diabetes and obesity.”
In an oral presentation titled, “Endoscopic, Duodenal-Jejunal Bypass Liner Exerts Robust Metabolic Effects: Accumulating Clinical Experience Across Four Studies,” results from four prospective, single-arm studies were shared involving a total of 130 patients from three countries implanted with EndoBarrier for a planned 12-month duration. Across all studies, the metabolic effects of EndoBarrier Therapy were robust and well established early in the treatment period. Key findings include:
- Among patients with type 2 diabetes, EndoBarrier Therapy demonstrated a significant reduction in HbA1c of -1.3 ± 0.19% from baseline, with more than half (52%) of diabetic patients achieving healthy blood glucose levels (HbA1C ≤ 7%) during the treatment period
- Patients across all studies (n=129) experienced total body weight loss of 14.2 ± 0.8kg from baseline
- Adverse events (AEs) were mostly gastrointestinal in nature and mild or moderate in severity
- Mean treatment duration for all patients with data available (n=126) was 10.2 months
Additionally, findings from three of the four prospective, single-arm studies involving a total of 87 obese patients with type 2 diabetes were highlighted in a poster titled “Robust Metabolic Improvement Observed with the Endoscopic, Duodenal-Jejunal Bypass Liner: 12 Month Data in Obese Type 2 Diabetes.” The poster features improvements in glycemia and weight.
Stuart A. Randle, president and CEO of GI Dynamics, commented, “We are pleased to report these data during the IDF World Congress this week and share the measurable impact we are seeing EndoBarrier Therapy have on HbA1c levels, weight loss and key cardiovascular risk factors. Diabetes and obesity remain two of the largest health concerns around the globe, and despite available pharmaceutical and surgical options, these conditions remain inadequately treated and controlled in many patients. EndoBarrier Therapy is uniquely positioned to help these people who are living with uncontrolled type 2 diabetes and obesity.”
More than 1,200 patients worldwide have been treated with EndoBarrier Therapy, the first endoscopically-delivered device therapy for patients with type 2 diabetes and obesity. It currently is approved for commercial use in Europe and Australia, as well as by a growing number of countries in South America and the Middle East.
About EndoBarrier Therapy
EndoBarrier Therapy is a revolutionary, non-surgical, non-pharmaceutical treatment proven to help people living with uncontrolled type 2 diabetes and obesity achieve rapid and dramatic reductions in blood sugar levels, as well as substantial weight loss. EndoBarrier Therapy is a 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. 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 the developer and marketer of EndoBarrier®, a breakthrough device that represents an entirely new class of non-surgical, non-pharmaceutical therapy for the treatment of type 2 diabetes and/or obesity. EndoBarrier is approved and commercially available in multiple countries outside the U.S. EndoBarrier is not approved for sale in the U.S. and is limited by federal law to investigational use only in the United States. GI Dynamics is conducting a pivotal clinical trial of EndoBarrier in the U.S. for the treatment of patients who have uncontrolled type 2 diabetes and are obese. 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.
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