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GI Dynamics Announces New EndoBarrier® Data from Research with GlaxoSmithKline Presented during Digestive Disease Week

2014年05月06日 AM07:30
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CHICAGO & SYDNEY

GI Dynamics, Inc. (ASX: GID), a medical device company developing innovative treatments for type 2 diabetes and obesity, today announced that new data from a study with GlaxoSmithKline (NYSE: GSK) on EndoBarrier® and its potential mechanism of action were presented at Digestive Disease Week 2014 (DDW) during an oral presentation titled, “Duodenal-jejunal Bypass Liner Increases Fasting and Postprandial Serum Levels of Bile Acids in Patients with Severe Obesity.”

“Early last year we formed an association with GSK to better understand the mechanism of action of the EndoBarrier and related hormonal and metabolic changes,” stated David Maggs, M.D., chief medical officer, GI Dynamics, Inc. “The increased level of bile acids we observed suggest that there may be a similar mechanism of action associated with EndoBarrier in the treatment of obesity and diabetes to that observed with gastric bypass. This mechanism may be the driver of the significant weight loss and glucose stabilization seen in patients treated with EndoBarrier.”

Researchers have proposed that increased postoperative levels of bile acids (BAs) may be tied to the effectiveness of a common type of gastric bypass surgery, Roux-en-Y gastric bypass (RYGB). To better understand the method of action of the EndoBarrier and how it may mimic RYGB, the study authors evaluated BA levels in 17 patients with severe obesity, with and without type 2 diabetes. Findings show that after 52 weeks of treatment with EndoBarrier, a 16% total body weight loss was accompanied by fasting total BAs levels over two-fold higher than those observed at baseline (1.3±0.3 vs 3±0.5 μMol/L, p<0.05); and following a standard test meal, nutrient-stimulated levels of total BAs were also increased by 70% (475vs805 AU, p<0.05).

“These findings show that EndoBarrier induced significant changes in the level of bile acids, which play a known role in the regulation of energy and glucose homeostasis,” stated Andrew Young, vice-president and head of endocrine biology, GlaxoSmithKline. “Although further exploration is needed, these data offer the beginning of a mechanistic explanation for the robust effects on body weight seen with EndoBarrier and support the continued investigation of EndoBarrier in patients with type 2 diabetes and obesity.”

EndoBarrier is a flexible, tube-shaped liner that is inserted endoscopically and placed at the beginning of the small intestine, where it remains for up to one year; after which it is removed during another endoscopic procedure. EndoBarrier has been approved in select countries internationally since 2010 and is available in Chile, Australia and a growing number of countries in Europe and the Middle East. It is currently under investigation in the U.S. as part of a multicenter, pivotal clinical trial (The ENDO Trial) for the treatment of patients who have uncontrolled type 2 diabetes and are obese.

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
GI Dynamics, Inc.
Robert
Crane, +1-781-357-3250
Chief Financial Officer
or
Australia
Hawkesbury
Partners Pty Limited
David Allen or John Granger, +61 2 9325 9046
or
Media
Enquiries:

United States/Europe:
Pure Communications Inc.
Dan
Budwick, +1-973-271-6085
or
Australia
Flourish PR
Angela
Ceberano, +61 3 9092 8445

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