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Data Presented at ADA Show the Effects of GI Dynamics’ EndoBarrier® Therapy on Glycemic Control and Reducing Diabetes Medication in Patients with Type 2 Diabetes and Obesity

2014年06月16日 PM07:30
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SAN FRANCISCO & SYDNEY

GI Dynamics, Inc. (ASX:GID), a medical device company developing innovative treatments for type 2 diabetes and obesity, today announced data findings from presentations that further demonstrate the acute effects of EndoBarrier® Therapy on glycemic control, its ability to reduce reliance on diabetes medications, including insulin, as well as findings that help explain its potential mechanism of action. These findings were presented in three poster presentations at the 74th Scientific Sessions of the American Diabetes Association in San Francisco.

“The data presented at ADA expand upon already established evidence presented recently at other medical meetings and further validate how the EndoBarrier device works to affect and improve glycemic control,” said David Maggs, M.D., chief medical officer, GI Dynamics, Inc. “The findings from these studies and analyses show that EndoBarrier positively impacts HbA1c and weight in patients with type 2 diabetes and obesity. Importantly, the findings also show that EndoBarrier Therapy can reduce reliance on diabetes medications, from oral agents to insulin therapy. This is an important consideration for physicians as they contemplate treatment regimens for their patients.”

Acute Effects on Glucose; Impact on Satiety and Insulin Requirements

Findings from the study, “The Acute Effect of EndoBarrier Treatment on Glucose Homeostasis in Obese Uncontrolled Diabetic Subjects,” evaluated the effects of the EndoBarrier device on glucose homeostasis, HbA1c, weight loss, insulin requirements and appetite in 33 patients. Glucose was monitored continuously for one week beginning two days before placement of the device.

Use of the EndoBarrier device resulted in an acute drop in average daily glucose by 29% within days post implantation, despite a reduction of 50% in insulin dose during this time. As early as 12 weeks after EndoBarrier insertion, subjects demonstrated a significant reduction in both weight (-8.9 kg) and HbA1c levels (-1.4%) leading to a decrease in insulin requirements. Interestingly, weight loss was accompanied by a decrease in appetite demonstrated by the visual analog scale.

“The ability of the EndoBarrier to acutely affect glucose homeostasis, before significant weight loss has had a chance to occur is fascinating and resembles reports on bariatric surgery,” stated Gabriella Lieberman, M.D., Institute of Endocrinology, Sheba Medical Center, Tel Aviv, Israel. “The fact that the device impacts all weight, glucose and appetite makes it attractive for the treatment of diabesity and makes one curious as to the underlying mechanism by which this device exerts its effects.”

Improvements in HbA1c, Weight Loss and Reduction of Oral Diabetes Medications

A pooled analysis of five open-label studies continues to demonstrate the effects of the EndoBarrier device to lower HbA1c, accelerate weight loss and reduce reliance on diabetes medications. This analysis, presented in the poster “Endoscopic, Duodenal-Jejunal Bypass Liner Exerts Robust Improvement in Glycemia and Body Weight in Obese Patients with Type 2 Diabetes,” evaluated 71 patients who completed 12 months of EndoBarrier Therapy.

The use of the EndoBarrier device resulted in a 1.4% median decrease in HbA1c (from 8.2% at baseline to 6.8); of these 57% achieved the recommended 7% HbA1c of the American Diabetes Association. Patients experienced a robust effect on total body weight loss with EndoBarrier Therapy, resulting in a 10.4% reduction (from 106.2 at baseline to 93.4 kg). Notably, patients were able to reduce use of background diabetes medications.

Increased Levels of Bile Acids Following Treatment with EndoBarrier

Research has indicated that bile acids levels may be tied to the effectiveness of gastric bypass surgery, such as Roux-en-Y gastric bypass (RYGB). The presentation, “Duodenal-Jejunal Bypass Liner Increases Bile Acids Levels in Patients with Severe Obesity and Type 2 Diabetes Mellitus” investigated the use of the EndoBarrier device and its effects on bile acids to explore its potential mechanism of action.

Primary and secondary bile acids levels were measured in seven patients with type 2 diabetes and obesity prior to placement of the EndoBarrier device and following removal at 52 weeks of treatment. After treatment, fasting total bile acids levels increased to 4.3±0.8 μmol/L (from 0.7±0.3 μmol/L baseline; p<0.05). Also, fasting primary (from 0.04±0.01 to 2.1±0.4 μmol/L) and secondary (from 0.07±0.02 to 1.5±0.4 μmol/L) bile acids levels increased from baseline (p<0.05 vs. baseline for both). These findings offer further insight into the mechanisms that underlie the therapeutic effect of EndoBarrier Therapy.

EndoBarrier Therapy does not work for everyone; and individual results may vary. In clinical studies, the most common complications were nausea, vomiting and upper abdominal pain. Other uncommon risks include infection, trauma, device migration and bleeding, any of which may result in endoscopic or surgical removal.

The EndoBarrier device is currently under investigation in the U.S. in a multicenter, pivotal clinical trial (The ENDO Trial) for the treatment of patients who have uncontrolled type 2 diabetes and are obese. EndoBarrier Therapy has been approved in select countries internationally since 2010 and is available in Chile, Australia and select countries in Europe and the Middle East.

About GI Dynamics

GI Dynamics, Inc. (ASX: GID) is the developer of EndoBarrier®, the first endoscopically-delivered device therapy approved for the treatment of type 2 diabetes and/or obesity. EndoBarrier is approved and commercially available in multiple countries outside the U.S. EndoBarrier is not approved for sale in the U.S. and is limited by federal law to investigational use only in the United States. GI Dynamics is conducting a pivotal clinical trial of EndoBarrier in the U.S. for the treatment of patients who have uncontrolled type 2 diabetes and are obese. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit www.gidynamics.com.

Forward-Looking Statements

This announcement contains forward-looking statements concerning: our development and commercialization plans; our potential revenues, costs, profitability and financial performance; our ability to obtain reimbursement for our products; our clinical trials, and associated regulatory submissions and approvals; the number and location of commercial centres offering the EndoBarrier®; and our intellectual property position. These forward-looking statements are based on the current estimates and expectations of future events by the management of GI Dynamics, Inc. as of the date of this announcement and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those indicated in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the possibility that clinical trials will not be successful or confirm earlier results; risks associated with obtaining funding from third parties; risks relating to the timing and costs of clinical trials, results of clinical trials, the timing of regulatory submissions, the timing and receipt of regulatory approvals, the timing and amount of other expenses; execution risks; competition; risks related to market acceptance of products; intellectual property risks; and assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches, future financial results and other factors. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.

CONTACT

Investor Enquiries:
United States
Robert Crane, Chief
Financial Officer
+1 781-357-3250
or
Australia
David
Allen or John Granger, Hawkesbury Partners Pty Limited
+61 2 9325
9046
or
Media Enquiries:
United States/Europe:
Dan
Budwick, Pure Communications Inc.
+1 973-271-6085
or
Australia
Angela
Ceberano, Flourish PR
+61 3 9092 8445

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