GI Dynamics announces clinical data about EndoBarrier Therapy at ASMBS meeting

Jun 23 2012

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."