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Product approval

GI Dynamics receive Australian approval for the EndoBarrier

EndoBarrier has the potential to assist patients with type 2 diabetes who are obese to control their diabetes and lose weight.”

Approval an important milestone for company

GI Dynamics has received Australian Therapeutic Goods Administration (TGA) approval for the EndoBarrier Gastrointestinal Liner (the EndoBarrier) for inclusion on the Australian Register of Therapeutic Goods (ARTG). The TGA has approved the use of the EndoBarrier for up to 12 months for the treatment of type 2 diabetes and obesity. With this approval, GI Dynamics will be able to commercially launch the EndoBarrier in Australia.

“There is an urgent need for less invasive, yet effective treatments for type 2 diabetes and obesity,” said Dr. Harry B Frydenberg, Director of the Epworth Centre for Bariatric Surgery, Victoria, Australia, and immediate past president of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). “We see many patients for whom existing pharmaceutical and lifestyle treatments are not effective in helping them manage their blood sugar levels or produce the weight loss they need. The EndoBarrier has the potential to assist Australians living with type 2 diabetes who are obese to control their diabetes and lose weight.”

Pharmaceutical treatments for type 2 diabetes often have diminishing benefits for patients despite more aggressive therapy. Surgical interventions, while effective, are associated with patient concerns about the risks of surgery and the irreversible aspects of some procedures. The EndoBarrier is a non-surgical, removable, physical barrier that enables food to bypass portions of the intestine, mimicking existing surgical interventions. This mechanism results in changes that ‘reset’ the body’s metabolic functions to a more normalized state.

Clinical data

Clinical trials involving more than 500 patients have demonstrated that the EndoBarrier results in improved glycaemic control and significant weight loss over the treatment period.

Previously, the company announced clinical results from three studies that demonstrate the positive effects of the EndoBarrier Gastrointestinal Liner on type 2 diabetes, weight loss and other metabolic factors. These data support the use of EndoBarrier as a primary therapy for the treatment of type 2 diabetes and obesity in patients with a BMI greater than 30 who have been unable to control their diabetes or lose weight through lifestyle changes and medications. Importantly, results from one study reveal for the first time the hormonal activity of EndoBarrier, which results in improved glycemic control and weight loss. These data and the benefits and role of EndoBarrier in type 2 diabetes were discussed during the session, “Novel Experimental Approaches for Diabetes/Obesity,” during the 2nd World Congress on Interventional Therapies for Type 2 Diabetes in New York.

Dr Lee M Kaplan, Associate Professor of Medicine, Harvard Medical School; Director, MGH Weight Center, Massachusetts General Hospital, Boston; and part of a panel discussion on novel approaches to diabetes and obesity at the 2nd World Congress, commented, “The findings from this study are striking. The EndoBarrier appears to affect the metabolic functions involved in type 2 diabetes through mechanisms similar to those that make bariatric surgery such an effective therapy for diabetes and obesity.”

In addition, data from two clinical trials reported at the meeting indicate that the EndoBarrier may be a candidate for the primary therapy of type 2 diabetes and obesity. In one study, Eduardo Moura, Director of Endoscopy, Hospital das Clinicas, University of São Paulo, evaluated use of the EndoBarrier in 22 patients with type 2 diabetes for one year.

After 12 months of EndoBarrier treatment, patients experienced a reduction in HbA1c levels from 8.9% at baseline to 6.6% (p<0.0001); decreased glucose levels from 175.6 at baseline to 137.8 mg/dL (p<0.0001); and an absolute weight loss of 20.2 kg (44 lbs.; p<0.0001), or 39% excess weight loss (p<0.0001). Importantly, metabolic functions including levels of insulin, cholesterol, LDL and triglycerides were normalised at one year.

In another study, Dr Alex Escalona, Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile, evaluated the effects of the EndoBarrier on weight loss and other cardiometabolic factors in 46 obese patients. At 12 months, the EndoBarrier treatment induced 20.0% total body weight loss (observed weight loss of 22.8 kg/50 lbs.), or 46.4% excess weight loss (p<0.0001).

The study also demonstrated that the EndoBarrier treatment improved key cardiometabolic risk factors, including a reduction in total cholesterol levels (195.0 mg/dL at baseline to 159.0 mg/dL; p<0.001) nd a reduction in diastolic blood pressure (85 mmHg at baseline to 71 mmHg; p<0.001). Data from a subset of six patients with type 2 diabetes achieved a mean reduction in HbA1c of 1.4 (p=0.05; 7.9% at baseline to 6.5%) following 12 months of treatment with the EndoBarrier.

“There is a need for a type 2 diabetes and obesity therapy that provides effective, long-term results. Pharmaceutical regimens often cause weight gain in diabetes patients over time, while surgical interventions to obesity carry risks and complications that often concern patients,” said Dr Escalona. “The EndoBarrier presents a unique solution to fill this treatment gap for type 2 diabetes and obesity. It has clinically proven rapid and long-lasting improvements in blood sugar control and weight loss, and offers physicians and patients an effective, non-surgical solution for the treatment of these diseases.”

The EndoBarrier has already received CE mark approval in Europe for up to 12 months of treatment for type 2 diabetes and obesity. The EndoBarrier is commercially available in Chile, Germany, the UK and the Netherlands, and GI Dynamics has also received an investigational device exemption approval to commence a pilot trial of the EndoBarrier in the US.

“Gaining approval to commercialize the EndoBarrier in Australia is another important milestone for our company,” said Stuart Randle, CEO of GI Dynamics. “We look forward to working with Australian diabetes experts and leading centers to bring the EndoBarrier to market in this country.”

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