GI Dynamics' EndoBarrier Gastrointestinal Liner Demonstrates Improvements in Blood Sugar Control and Facilitates Weight Loss in People Living with Type 2 Diabetes

Data from Clinical Studies Presented at Digestive Disease Week

LEXINGTON, Mass. & NEW ORLEANS--(BUSINESS WIRE)--May 3, 2010 - GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced results from two ongoing studies of its EndoBarrier™ Gastrointestinal Liner. One study evaluated the EndoBarrier as a treatment in patients who are obese and living with type 2 diabetes and the second study evaluated the EndoBarrier in patients who are obese. Notably, in the diabetes study at week 24 (n=16), the change in HbA1c was -1.5±0.4% while 58% of the subjects (n=7/12 with data) achieved HbA1c of 7% or less. These data were presented by Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile at Digestive Disease Week (DDW) 2010 in New Orleans, La.

Stuart A. Randle, chief executive officer of GI Dynamics, stated, “GI Dynamics is preparing to commercialize the EndoBarrier in Europe, and we are committed to delivering a solution for patients combating type 2 diabetes and weight gain. We recognize that patients living with diabetes and the physicians who treat them are looking for safe and effective alternatives to traditional pharmaceutical and surgical therapies, and we believe these new data underscore the significant opportunity for our innovative approach in addressing these serious metabolic conditions.”

The EndoBarrier was implanted in 61 patients in two prospective, single arm studies at two institutions in Brazil and Chile. One study enrolled 39 patients who were obese with a mean BMI of 43.8 ± 0.9 kg/m2 (range: 35.4-58.2 kg/m2) while a second study enrolled 22 patients who were obese with a mean BMI of 44.9 ± 1.6 kg/m2 (range: 35.6-59.6 kg/m2) and with type 2 diabetes. These patients had a mean baseline HbA1c of 8.9 ± 0.4% (range: 6.7-11.6%). Assessments in both trials were similar and included monthly weights and safety evaluations. The diabetes trial also assessed blood sugar levels (HbA1c) at all post-implant follow-up visits.

The mean change in weight at 24 weeks (n=48) was -15.0±1.1kg (-27.0±1.7% excess weight; -13.1±0.9% total body weight). In the diabetes study at week 24 (n=16), the change in HbA1c was -1.5±0.4% while 58% of the subjects (7/12 with data) achieved HbA1c of 7% or less. There was one migration of the EndoBarrier prior to 24 weeks (1.6%), a significant improvement (p< 0.05) over the first generation design (31%). There were an additional eight early removals due to device-related adverse events such as GI discomfort. All implants were delivered and removed endoscopically with the implant procedures taking less than 30 minutes and removal procedures taking less than 15 minutes.

“These data are based on our second-generation EndoBarrier which was designed for a longer duration of therapy. Subsequent to the successful completion of the trials evaluating EndoBarrier treatment for 6 months, we have successfully completed a clinical trial evaluating the EndoBarrier for 12 months with impressive results in both weight loss and glycemic improvement,” stated Andy Levine, founder and chief technology officer of GI Dynamics. “Based on the consistent and enhanced results we have seen at 12 months, we plan to pursue commercialization and additional clinical development for this longer treatment period, and we look forward to sharing the results from 12 months of EndoBarrier treatment at IFSO later this year.”

Addressing Unmet Need for Treating Type 2 Diabetes and Obesity

GI Dynamics is defining a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Unlike traditional pharmaceutical approaches, non-surgical therapeutics remove the burden of dose regimen compliance from the patient. Additionally, non-surgical therapeutics hold the potential to improve the patient's overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented.

About the EndoBarrierGastrointestinal Liner

The EndoBarrier is a non-surgical therapy to treat type 2 diabetes and obesity approved for use in Europe and in advanced stages of development in the United States. Clinical trials to date involving more than 280 patients have demonstrated significant weight loss and diabetes improvement with the EndoBarrier Gastrointestinal Liner.

The EndoBarrier Gastrointestinal Liner is placed in the GI tract endoscopically (via the mouth) to create a barrier between food and the wall of the intestine. Physicians believe that preventing food from coming into contact with the intestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery. A growing body of preclinical and clinical evidence supports the potential for EndoBarrier Gastrointestinal Liner to change the treatment landscape for patients who are obese and living with type 2 diabetes, and patients with severe weight problems.

About GI Dynamics

GI Dynamics is focused on developing effective, non-surgical approaches for treating type 2 diabetes and obesity. The company's patented EndoBarrier™ Technology has the potential to deliver medical interventions for patients combating weight problems and diabetes or diabetes risk factors. Data from clinical trials demonstrate that the EndoBarrier Gastrointestinal Liner, an advanced device in the EndoBarrier portfolio, may provide rapid improvement in glycemic control and significant weight loss by modifying metabolic pathways. GI Dynamics is collaborating with experts in endocrinology, gastroenterology, bariatric surgery and medical weight loss on these efforts.

Based in Lexington, Massachusetts and founded in 2003, GI Dynamics is backed by top-tier investors including Advanced Technology Ventures, Catalyst Health Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson Development Corporation, Medtronic, Inc., and Polaris Venture Partners. For more information, visit GI Dynamics online at www.gidynamics.com.

 

Contact: Pure Communications Inc.
Caton Lovett, 910-232-7166
or
GI Dynamics
Jonathan Hartmann, 781-357-3300
jhartmann@gidynamics.com

 

Posted: May 2010

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