Novel Non-Surgical Therapy Dramatically Increases Weight Loss In Obese Patients; Results From Pilot Clinical Study Presented At ASMBS

Main Category: Obesity / Weight Loss / Fitness
Article Date: 29 Jun 2009 - 3:00 PDT

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GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and obesity, today announced results from a pilot clinical study which demonstrated the substantially enhanced weight loss effects of combining the company's EndoBarrier Gastrointestinal Liner with a new EndoBarrier Flow Restrictor. The EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet of the stomach and is designed to delay gastric emptying, an additional mechanism which adds to the therapeutic effects of the liner. The results were presented today at the 26th annual meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS).

In this initial, single-center study of 10 morbidly obese people (body mass index between 35.8 and 47.8), participants achieved the following results over a twelve-week period during which the device was implanted (median values reported):

- Percent Excess Weight Loss (%EWL): 39.6%
- Weight Loss: 36.7 pounds (16.7 kilograms)
- Percent Total Body Weight Loss (%TBWL): 15.4%

All 10 patients completed the 12-week study. The most common side effects included mild to moderate abdominal pain, nausea and vomiting.

"These results are unparalleled for a non-surgical treatment for obesity," stated Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile and lead investigator for the pilot study. "Like the United States, Chile is struggling with a growing epidemic of obesity and related metabolic disorders and life-threatening conditions. Traditionally, non-surgical treatment approaches have proven insufficient for the morbidly obese, but these data suggest we may have an effective new option to offer these patients. Based on the excellent results I observed in this pilot study, I believe the combination device may offer hope for patients battling significant weight loss needs and associated co-morbidities, and clearly deserves further study in longer-term, controlled clinical trials."

Clinical trials involving more than 250 patients have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner. These latest data suggest that the combination of the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor could enhance the effectiveness of the liner by nearly doubling the amount of weight loss achieved by using the liner alone. These clinical data are consistent with recently reported preclinical data assessing the combination of devices in a porcine model. The preclinical data were featured at the Society of American Gastrointestinal and Endoscopic Surgeons 2009 Annual Meeting in April.

"We are very pleased with the results seen in this pilot study and the increased effect on weight loss achieved by the combination of the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor," said Stuart A. Randle, chief executive officer of GI Dynamics. "We believe that the combination of these devices impacts weight loss through distinct mechanisms of action and may truly represent a breakthrough in non-surgical treatment of type 2 diabetes and obesity. GI Dynamics is conducting ongoing clinical studies investigating the synergistic effects of the combined devices. Our platform is well positioned to deliver a portfolio of devices that will allow physicians to choose the most appropriate non-surgical therapy for each patient's individual weight loss goals and glycemic control needs."

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 EndoBarrier™ Gastrointestinal Liner

The patented EndoBarrier Gastrointestinal Liner is an advanced investigational, non-surgical medical device based on the EndoBarrier Technology platform for treating type 2 diabetes and obesity. 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 dramatically change the treatment landscape for people living with type 2 diabetes, obese people at risk for type 2 diabetes, and people with severe weight problems.

Source
GI Dynamics