GI Dynamics, Inc. (Company or GI Dynamics) (GID.AX) announced today that it has received full approval from the U.S. Food and Drug Administration (FDA) to commence a 25-site pivotal clinical trial of EndoBarrier® for the treatment of patients who have uncontrolled type 2 diabetes and are obese. Data garnered from the U.S. clinical study, named the ENDO Trial, will be used to support a Premarket Application (PMA) for EndoBarrier. This approval follows the Company’s announcement in August that it had received conditional approval from the FDA.
EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. In 12 clinical studies conducted outside the United States and one conducted in the United States, with more than 500 patients, EndoBarrier has been shown to achieve rapid reductions in blood sugar levels, improvement of cardiovascular risk factors including blood pressure, cholesterol and triglycerides, and weight loss of approximately 20 percent in 12 months1, 2. EndoBarrier received CE Mark approval in 2010, and approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity for up to 12 months. EndoBarrier is currently commercially available in select countries in Europe, including Germany, Austria, the United Kingdom and the Netherlands, as well as Australia and Chile.
“Over the past several years, we have successfully completed extensive clinical studies and achieved several regulatory approvals outside the U.S., and it has been extremely rewarding to see the benefits EndoBarrier has brought to people living with type 2 diabetes,” said Stuart A. Randle, president and chief executive officer, GI Dynamics. “We are very pleased to now have full approval in the U.S. to commence a pivotal trial of this novel therapy. We look forward to providing updates on the progress of the ENDO trial and to submitting the results for PMA approval to sell EndoBarrier in the United States.”
About The ENDO Trial
The ENDO Trial is a randomized, multi-center, double-blind, sham controlled trial that is expected to enroll approximately 500 people living with uncontrolled diabetes and obesity who meet the enrollment criteria at 25 sites in the United States. The trial is designed to assess improvements in diabetes over a treatment period of up to 12 months. The primary endpoint of the trial is improvement in HbA1c (a key blood sugar measure for diabetes); secondary measures include weight loss and improvements in select cardiovascular risk factors, such as cholesterol. People interested in learning more about The ENDO Trial should call (781) 357-3252.
About Type 2 Diabetes and Obesity
Estimates indicate that type 2 diabetes affects more than 23 million people in the United States3, and approximately 320 million people worldwide4. Type 2 diabetes, which accounts for approximately 90 percent of all cases of diabetes, occurs when the pancreas has reduced effectiveness in insulin production associated with an increase in insulin resistance. The diagnosis of type 2 diabetes usually occurs after the age of 40 and is often, but not always, associated with obesity.
About GI Dynamics
GI Dynamics, Inc. (GID.AX) is pioneering the development and commercialization of effective, non-surgical treatments targeting the large and growing global patient populations with type 2 diabetes and obesity. The company’s flagship product, EndoBarrier®, is a novel, non-surgical device proven to lower blood glucose levels and promote weight loss in diabetic patients and/or obese patients during the implant period. GI Dynamics currently markets EndoBarrier in select regions in Europe, South America and Australia and is planning near-term commercial expansion into additional markets. EndoBarrier is not approved for sale in the United States and is considered investigational. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit www.gidynamics.com.
Forward-Looking Statements
This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to commercialize our EndoBarrier® including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products including our ability to obtain reimbursement for our products; our expectations with respect to our clinical trials, including enrolment in or completion of our clinical trials and our associated regulatory submissions and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position. Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. GI Dynamics does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. GI Dynamics may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, described in “Risk Factors” in our Prospectus lodged with the Australian Securities & Investments Commission on 3 August 2011.
[1] Moura, GHD, et al, One Year Results of an Endoscopic, Duodenal-Jejunal Exclusion Device for Weight Loss and Control of Type 2 Diabetes. Hospital das Clinicas, University of São Paulo, São Paulo, Brazil. DT&T, February 2012, vol 14, no.2:183-189.
[2] Escalona, A., et al, “Post-explant follow-up after 12 months implantation of an endoscopic duodenal-jejunal bypass liner.” Department of Digestive Surgery. Faculty of Medicine Pontificia Universidad Católica de Chile. Annals of Surgery, June 2012, Vol 255, Issue 6, p 1080–1085.
[3] Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011.
[4] International Diabetes Federation, 5th edition of the Diabetes Atlas, 2011.
Contact:
Investor Enquiries:
United States
Robert Crane, +1 (781) 357-3250
Chief Financial Officer
or
Australia
Inteq Limited
Kim Jacobs, +61 2 9231 3322
or
Media Enquiries:
North America/Europe:
Pure Communications Inc.
Dan Budwick, + 1 (973) 271-6085
or
Australia:
Buchan Consulting Group
Haley Price, +61 3 8866 1215
