Data from two patient registries in commercialized markets, clinical research and a meta-analysis of 13 clinical studies highlighted in four presentations at EASD
LEXINGTON, Mass. & BARCELONA, Spain – 25 September 2013 – GI Dynamics, Inc. (ASX: GID) announced today that EndoBarrier® Therapy data from two patient registries in commercialized markets (U.K. and the Netherlands), clinical research from Germany and a meta-analysis of 13 clinical studies were the focus of four presentations at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD) held 23 – 27 September 2013 in Barcelona, Spain.
“Type 2 diabetes requires new treatment options that help patients achieve metabolic control as existing options are not adequately addressing the needs of patients and physicians,” stated David Maggs, M.D., chief medical officer, GI Dynamics. “There is a growing recognition among physicians worldwide of the strong impact that EndoBarrier Therapy can have and where it fits within the existing treatment options for type 2 diabetes and obesity. These data presented at EASD and data from previous clinical studies, continue to demonstrate and validate the use of EndoBarrier Therapy as part of an effective type 2 diabetes treatment program.”
EndoBarrier Therapy Oral Presentation
During the oral presentation, “Interim 12-month results from a post-market clinical trial of DJBL treatment outcomes in subjects with type 2 diabetes and/or obesity,” Dr. Julian Teare, Imperial College of London, discussed health improvements achieved through EndoBarrier Therapy in 32 patients. From baseline, patients experienced a one percent decrease in HbA1c, enabling them to achieve better overall glycemic control. In addition, patients achieved a mean weight loss of 26.4 lb (11 kg), along with reductions in blood pressure, cholesterol and triglycerides.[i]
EndoBarrier Therapy Poster Presentations
Additional poster presentations on EndoBarrier Therapy were featured during the meeting that continue to demonstrate positive treatment outcomes and utility in type 2 diabetes.
- Implantation of an endoscopically-deployed duodenal-jejunal bypass liner in obese type 2 diabetes subjects: 8-month follow-up of 10 subjects
Lead investigator: Y. Krepak, M.D., Herz- und Diabeteszentrum NRW; Bad Oyenhausen, Germany
- Six-month follow-up results from a registry observing Durdenal-Jejunal Bypass Liner treatment outcomes in subjects with type 2 diabetes and/or obesity
Lead investigator: P. Koehestanie, M.D., Jeroen Bosch, Ziekenhuis; Nijmegen, the Netherlands
- Duodenal-Jejunal Bypass Sleeve for obesity and type 2 diabetes: systematic review with meta-analysis of clinical studies
Lead investigator: N. Hedback, M.D., University of Copenhagen; Copenhagen, Denmark
“We are very pleased with the progress that we have made in our key European markets and the growing adoption of EndoBarrier Therapy by endocrinologists, as evidenced by the initiation of clinical studies by leading health authorities in France and the United Kingdom,” said Stuart A. Randle, president and chief executive officer, GI Dynamics. “The data presented at EASD and the findings from these ongoing studies are designed to help further establish EndoBarrier Therapy as a standard treatment option for type 2 diabetes with local health authorities and in influential treatment guidelines.”
EndoBarrier Therapy is currently the subject of clinical studies being conducted in France and the U.K. The French Ministry of Social Affairs and Health approved funding for the ENDOMETAB trial, a large, randomized, multicenter clinical utility study of EndoBarrier Therapy. The study will be coordinated by the University Hospital of Lille. ENDOMETAB is part of the soutien aux techniques innovantes couteuses (STIC) program, which provides government funding for innovating medical technologies that have been validated by prior clinical studies with a view toward establishing reimbursement for new devices. In the U.K., the Association of British Clinical Diabetologists has initiated the REVISE-Diabesity study, which is being funded by a grant from the Diabetes Care Trust (ABCD), Registered Charity Number 1139057 in the U.K., and is supported by the U.K.’s publicly-funded health system, the National Health Service (NHS), as one of the National Institute for Health Research Clinical (Diabetes) Research Network Portfolio Studies.
EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between ingested food and a portion of the wall of the intestine. Inserted endoscopically (through the mouth without any cutting or scarring of tissue), the EndoBarrier liner prevents the interaction of food with enzymes and hormones in the proximal intestine. In effect, food bypasses the duodenum, but without surgery or permanent changes to the anatomy. In clinical studies, more than 80% of patients were able to reach healthy blood glucose levels (HbA1c ≤ 7.0%) and achieve weight loss of approximately 15-20 percent within one year.[ii],[iii] EndoBarrier Therapy is currently available in seven European countries, as well as in Australia, Chile and Israel.
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.
[i] Not included in Instructions for Use.
[ii] 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.
[iii] Escalona, A., et al, “Weight Loss and Metabolic Improvement in Morbidly Obese Subjects Implanted for 1 Year With 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.