GI DYNAMICS, INC. GI Dynamics, Inc. - ASX Announcement
New Data Presented at ADA Demonstrate Early Effect of EndoBarrier Therapy on Glucose Control and Bile Acid RegulatorsOral and poster presentations at American Diabetes Association annual meeting reinforce value of duodenal-jejunal exclusion for treating type 2 diabetes and obesity
LEXINGTON, Massachusetts & SYDNEY, Australia - 8 June 2015 - GI Dynamics, Inc. (ASX: GID), a medical device company, provides innovative treatments for type 2 diabetes and obesity, today announced new data showing the effect of EndoBarrier® Therapy on bile acid regulators and other anthropometric, biochemical and hormonal parameters. Professor Martin Haluzik of the IKEM Research Centre Prague, Czech Republic, presented these findings during an oral session at the 75th Annual Meeting of the American Diabetes Association in Boston, Massachusetts.
Prof. Haluzik's presentation, titled 'Ten Months of Treatment with Endoscopic Duodenal- jejunal Bypass Liner Reduces Glycemic Variability, Increases Serum Fibroblast Growth Factor
19 (FGF-19), and Partially Restores the Incretin Effect in Obese Subjects with Type 2 Diabetes Mellitus,' follows the progress of 30 obese patients with type 2 diabetes after being implanted with the EndoBarrier gastrointestinal liner.
Study results show that EndoBarrier Therapy led to an improvement in multiple glycemic parameters and a sustained decrease in body weight and body fat. Notably, fibroblast growth factor 19 (FGF-19), a potent regulator of bile acid, glucose and fat metabolism, was markedly increased by EndoBarrier Therapy. In addition, EndoBarrier Therapy also raised levels of the incretin hormone GLP-1.
"The positive effects of EndoBarrier Therapy on glycemia, body weight and body fat are well documented. However, this data shows that EndoBarrier Therapy also elevates FGF-19 levels - a naturally occurring protein that is thought to be involved in bile acid synthesis and more general metabolic homeostasis. More specifically, FGF-19 is active in a specific metabolic axis that has drawn recent attention as a putative pharmacological target for the treatment of fatty liver disease," commented David Maggs, MD, chief medical officer of GI Dynamics.
Other posters pertaining to EndoBarrier Therapy presented at this year's ADA meeting included the following:
www.gidynamics.com
US OFFICE & HEADQUARTERS: 25 Hartwell Avenue, Lexington MA 02421 T +1 (781) 357-3300 F +1 (781) 357-3301
EUROPEAN OFFICE: Prinzenallee 7, 40549 Dusseldorf, Germany T: +49 211 5239 1572
AUSTRALIAN OFFICE: Level 8, 17-19 Bridge Street, Sydney, NSW 2000 T +61 2 9325 9046
GI Dynamics, Inc., is a corporation incorporated in Delaware, USA, whose stockholders have limited liability. ARBN 151 239 388
GI Dynamics, Inc. - ASX Announcement Page 2
Weight Loss-independent Improvement in Type 2 Diabetes with EndoBarrier TherapyL. Kaplan, et al, Boston, MA
The metabolic impact of 12 months of EndoBarrier Therapy was studied in obese, type 2 diabetes subjects to assess the metabolic changes in subjects with minimal weight loss (≤ 2 kg) early after implantation, and the estimated effect of weight on A1C with baseline A1C and weight as independent variables. The results provide evidence for both weight loss dependent and independent metabolic effects of EndoBarrier Therapy. The contribution of a weight- independent effect appears clinically significant.
Metabolic Improvements Observed in Subjects Receiving EndoBarrier: A Pooled Analysis of Clinical TrialsJ. Teare, et al, London, United Kingdom
A pooled analysis of results from six EndoBarrier clinical studies showing EndoBarrier Therapy elicited significant metabolic improvements and weight loss with an acceptable safety profile among 211 obese subjects with comorbidities.
About GI DynamicsGI Dynamics, Inc. (ASX: GID) is the developer of EndoBarrier®, the first endoscopically-delivered device therapy approved for the treatment of obese type 2 diabetes with BMI ≥ 30 kg/m2, or obese patients with BMI ≥ 30 kg/m2 with ≥ 1 comorbidities, or obese patients with BMI >35 kg/m2. The liner is indicated for a maximum implant duration of 12 months. 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 StatementsThis announcement contains forward-looking statements concerning: our development and commercialization plans; our potential revenues and revenue growth, costs, excess inventory, 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, the timing of regulatory submissions, the timing, receipt and maintenance of regulatory approvals, the timing and amount of other expenses, and the timing and extent of third-party reimbursement; risks associated with commercial product sales, including product performance; competition; risks related to market acceptance of products; intellectual property risks; risks related to excess inventory; risks related to assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches, future financial results and other factors including those described in our filings with the U.S. Securities and Exchange Commission. 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.
www.gidynamics.com
US OFFICE & HEADQUARTERS: 25 Hartwell Avenue, Lexington MA 02421 T +1 (781) 357-3300 F +1 (781) 357-3301
EUROPEAN OFFICE: Prinzenallee 7, 40549 Dusseldorf, Germany T: +49 211 5239 1572
AUSTRALIAN OFFICE: Level 8, 17-19 Bridge Street, Sydney, NSW 2000 T +61 2 9325 9046
GI Dynamics, Inc., is a corporation incorporated in Delaware, USA, whose stockholders have limited liability. ARBN 151 239 388
GI Dynamics, Inc. - ASX Announcement Page 3
Investor Enquiries: Media Enquiries:
United States
Michael Dale, President & CEO
+1 (781) 357-3310
United States/Europe/Australia:
Bill Berry, Berry & Company Public Relations LLC
+1 (212) 253-8881
Australia
David Allen or John Granger
Hawkesbury Partners Pty Limited
+61 2 9325 9046
www.gidynamics.com
US OFFICE & HEADQUARTERS: 25 Hartwell Avenue, Lexington MA 02421 T +1 (781) 357-3300 F +1 (781) 357-3301
EUROPEAN OFFICE: Prinzenallee 7, 40549 Dusseldorf, Germany T: +49 211 5239 1572
AUSTRALIAN OFFICE: Level 8, 17-19 Bridge Street, Sydney, NSW 2000 T +61 2 9325 9046
GI Dynamics, Inc., is a corporation incorporated in Delaware, USA, whose stockholders have limited liability. ARBN 151 239 388
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