Retrospective Analysis Presented at the Annual Meeting of the American Association of Clinical Endocrinologists
LAS VEGAS, Nevada, United States and SYDNEY, Australia – 15 May 2014 – GI Dynamics, Inc. (ASX: GID), a medical device company developing innovative treatments for type 2 diabetes and obesity, today announced new findings that show that EndoBarrier® Therapy enabled a rapid reduction in, and elimination of, insulin therapy by patients with type 2 diabetes and obesity. These findings from a retrospective analysis of 100 patients in Australia were presented at the American Association for Clinical Endocrinology 23rd Annual Meeting and Scientific Congress in Las Vegas, Nevada.
“While based on a small number of patients, these findings show that EndoBarrier Therapy has a real, immediate impact on glycemic levels,” said Prof Reginald V. Lord, M.D., F.R.A.C.S., St. Vincent’s Clinic and Macquarie Hospital, Sydney. “We are pleased that EndoBarrier Therapy offers the opportunity for patients to reduce their reliance on insulin, which is often viewed as a last resort treatment for diabetes. We view EndoBarrier Therapy as a non-surgical treatment option that possibly extends the utility of their existing pharmaceutical treatment regimens.”
The retrospective analysis reviewed the medical records and nationwide patient registry of the first 100 patients in Australia who received EndoBarrier Therapy. Of these 100 patients, 11 required the use of insulin to manage their type 2 diabetes prior to receiving EndoBarrier Therapy. Following placement of the EndoBarrier, there was an overall lowering of insulin requirements based on the protocol at the two treatment centers.
The analysis revealed that six (54%) of the 11 insulin-treated patients with type 2 diabetes were able to completely cease use of insulin therapy during EndoBarrier Therapy.
The remaining five insulin-treated patients were also able to decrease their insulin therapy in injection frequency, daily dosage or both. All patients maintained use of oral diabetes medications. Moreover, this overall reduction in concomitant insulin use was accompanied by a lowering of HbA1c to 7.3%, from a HbA1c of 8.8% at baseline. The analysis also demonstrated the positive effects of EndoBarrier Therapy on weight; patients achieved a median weight loss of 11.1 kg at study follow up.
“Earlier research has demonstrated that EndoBarrier Therapy has rapid and sustained effects on glycemic control and this analysis further supports those findings,” said David Maggs, M.D., chief medical officer of GI Dynamics. “As we expand our global patient experience, we are learning more about how EndoBarrier Therapy can help reduce or, in some cases, altogether eliminate the use of insulin in those patients who have progressed to requiring insulin treatment. Based on the data and patient experience to date, we believe EndoBarrier Therapy is emerging as a highly attractive complement to existing pharmaceutical regimens and an important treatment option to consider for people with type 2 diabetes and obesity.”
Individual results in patients using the EndoBarrier device will vary. Patients and their physicians should always thoroughly read the product labeling. Patients should discuss the risks and benefits of using the EndoBarrier device with their physician to determine if EndoBarrier Therapy is right for them.
EndoBarrier Therapy is the world’s first and only endoscopically-delivered device technology that improves type 2 diabetes and obesity by lowering blood sugar and weight at the same time. 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. It 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 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.
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.
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.