BOSTON and SYDNEY — 4 July 2018 — GI Dynamics® Inc. (ASX: GID), a medical device company that is developing EndoBarrier® for patients with type 2 diabetes and obesity, is pleased to announce further positive results from the ongoing National Health Service (NHS) EndoBarrier Service in the U.K., which Robert Ryder, MD, of Sandwell and West Birmingham Hospitals presented at the American Diabetes Association’s (ADA) 78th Scientific Sessions.
The study, “U.K.’s 1st National Health Service (NHS) EndoBarrier Service: Outcomes in 1st 38 Patients to Reach 6 Months After Device Explant,” is based on the outcome from 38 of the 62 patients who completed six months post EndoBarrier removal since the NHS Service began in October 2014. Of these patients, 31 attended the 6-month follow-up appointment, making it possible to assess the outcome post treatment.
The primary outcomes of HbA1c, weight and BMI showed a significant reduction at explant and six months post explant compared to baseline values. Patients also saw a significant reduction in systolic blood pressure. A major triumph is that patients who were on insulin (n=20) saw a significant reduction in their daily dosage which remained significant after explant. Thirty-five percent of these patients discontinued the use of insulin even after EndoBarrier was explanted.
Of the 31 patients, 21 (68 percent) maintained the treatment effect post explant. For the patient cohort that did not retain benefit, some mean reduction in HbA1c was still maintained. Many of the patients who saw their benefit deteriorate reported other personal matters in their lives and 70 percent were diagnosed with depression.
This study is an extension of the poster “Maintenance of Efficacy After EndoBarrier in UK 1st National Health Service (NHS) EndoBarrier Service,” presented in June 2017 at ADA’s 77th Scientific Sessions, consisting of data for 12 patients who reached the six month post explant point.
“We are pleased to present additional data suggesting that EndoBarrier can provide substantial clinical benefit post removal,” said Robert Ryder, MD. “The mean reduction in HbA1c of 2.5 percent and mean reduction in weight of 16kg are clinically significant, especially as many of these patients’ gains were accompanied by significant reduction in diabetic medications, in particular insulin”
“This release of clinical data further reinforces treatment durability of EndoBarrier after removal, with 68 percent of patients retaining significant clinical benefit six months after removal,” said Scott Schorer, president and chief executive officer of GI Dynamics. “We are pleased that expanded clinical data indicates EndoBarrier has a treatment effect that extends beyond the treatment period in many patients. GI Dynamics is focused on providing patients with the ability to improve their health and maintain a healthy lifestyle.”
About GI Dynamics
GI Dynamics®, Inc. (ASX:GID) is the developer of EndoBarrier®, the first endoscopically-delivered device therapy for the treatment of type 2 diabetes and obesity. EndoBarrier is not approved for sale and is limited by federal law to investigational use only. Founded in 2003, GI Dynamics is headquartered in Boston, Massachusetts. For more information please visit gidynamics.com.
This announcement may contain forward-looking statements. These forward-looking statements are based on GI Dynamics management’s current estimates and expectations of future events as of the date of this announcement. Furthermore, the estimates are subject to several 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 our ability to continue to operate as a going concern, our ability to maintain compliance with our obligations under the Convertible Loan Note executed with Crystal Amber Fund Limited, obtaining and maintaining regulatory approvals required to market and sell our products; obtaining funding from third parties; the consequences of stopping the ENDO trial and the possibility that future clinical trials will not be successful or confirm earlier results; 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; the timing and extent of third-party reimbursement; intellectual-property risk; risks related to excess inventory; and risks related to assumptions regarding the size of the available market, the 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, one 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 or future events or otherwise, unless we are required to do so by law.