Obese Patients Achieved Mean Weight Loss of 20%; Data Presented at IFSO 2010 World Congress
LEXINGTON, Mass. & LOS ANGELES--(BUSINESS WIRE)-- GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced data with the EndoBarrier™ Gastrointestinal Liner at 12 months showing significant weight loss and cardiovascular and metabolic improvements in obese patients. Following 12 months of therapy, patients lost an average of 20 percent of their body weight, or 49.5 pounds. The EndoBarrier is a non-surgical therapy to treat type 2 diabetes and obesity approved for use in Europe and in advanced stages of clinical development in the United States. Clinical trials to date involving more than 300 patients have demonstrated significant weight loss and diabetes improvement with the EndoBarrier.
“We now have data demonstrating the safety and efficacy of 12 months of EndoBarrier therapy in clinically obese patients and the impact this treatment approach has on related health issues such as hypertension, dyslipidemia and metabolic syndrome,” commented Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile, member of GI Dynamics’ scientific advisory board and lead investigator of the study. “We have previously reported notable HbA1c results achieved in patients with type 2 diabetes after nine months of treatment, and now a subset of our 12-month data in obese patients with type 2 diabetes reinforces the significant opportunity for EndoBarrier to provide a new, non-surgical solution for the treatment of type 2 diabetes.”
These data were presented in an oral presentation this week at the International Federation for Surgery of Obesity and Metabolic Disorders (IFSO) 2010 World Congress in Los Angeles, Calif. The clinical trial was designed to examine the safety and efficacy of the EndoBarrier in obese patients over 12 months. Twenty-four obese patients with an average weight of 110.7 kg and average body mass index (BMI) of 45.3 were successfully implanted with the EndoBarrier. The patients also exhibited baseline co-morbidities including type 2 diabetes, hypertension, dyslipidemia and metabolic syndrome.
At 12 months of treatment with the EndoBarrier, patients achieved:
- Mean absolute weight loss of 22.5 kg (49.5 lbs), or 20.0% (p = <0.0001)
- Mean excess weight loss (EWL) of 46.3%
Patients also experienced the following improvements in key cardiovascular risk factors:
- Reduction in total cholesterol levels from 196.5 mg/dL at baseline to 161.0 mg/dL (p = <0.0001)
- Reduction in diastolic blood pressure from 84.8 mmHg at baseline to 71.2 mmHg (p= <0.0001)
Notably, data from a subset of six patients with type 2 diabetes with mean baseline HbA1c of 7.9% showed that patients achieved a mean reduction in HbA1c of 1.4 (p=0.05) following 12 months of treatment with the EndoBarrier.
“At a time when physicians are seeking alternatives to pharmaceutical and surgical interventions for obesity and type 2 diabetes, these 12-month data are further support for the market potential of EndoBarrier and pave the way for our upcoming launch of EndoBarrier in Europe this fall,” said Stuart A. Randle, chief executive officer of GI Dynamics. “We believe that our breakthrough non-surgical therapeutic has the potential to change the treatment paradigm for obese patients who want to regain control of their type 2 diabetes while also potentially improving other factors associated with these conditions.”
In addition, EndoBarrier data was highlighted at IFSO in the Latin American Course by Dr. Escalona and the “Innovations in Endoluminal Procedures” session by Jan Willem Greve, M.D., Ph.D., Gastrointestinal and Bariatric Surgery, Atrium Medical Center Parkstad, Heerlen, Netherlands and member of GI Dynamics’ scientific advisory board, which took place on Saturday, September 4, 2010.
About the EndoBarrier™ Gastrointestinal 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 clinical development in the United States. Clinical trials to date involving more than 300 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 the 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.
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INDUSTRY KEYWORDS: Health Clinical Trials Medical Devices Diabetes
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