German Registry Releases Positive EndoBarrier Data at EASD
BOSTON, Massachusetts, United States, and SYDNEY, Australia – November 9, 2016, AEDT
- Mean reduction in absolute HbA1c of 1.3%
- Insulin usage dropped 42%
- GLP-1 usage reduced in 78% of patients
- Excess weight loss of 15kg, or 29% of excess weight
- 234 patients included (March 2016)
GI Dynamics, Inc. (ASX: GID) (GI Dynamics or the Company), a medical technology company that has developed an innovative device to improve outcomes for patients diagnosed with type 2 diabetes and obesity, continues to demonstrate clinical benefit in Germany.
The German EndoBarrier registry, which is run at the University Hospital Hamburg-Eppendorf (UKE), recently released positive data at the EASD (European Association for the Study of Diabetes). Dr Nina Riedel of UKE presented data from 234 patients at the EASD in Munich, Germany.
The EndoBarrier produced clinically relevant results, lowering absolute HbA1c mean from 8.5% to 7.2%. This occurred in concert with a lowering of antidiabetic medication in 78% of patients, and reducing the injected dose of Insulin by 42% on a mean basis.
Dr. Riedel said, “Patients significantly benefitted from improvement of HbA1c, reduction of antidiabetic medication, reduction of weight and were able to improve obesity-associated comorbidities.”
Excess weight also dropped by a mean of 15kg, which represented a 29% drop in excess weight. In addition, a mean drop of 10cm waist circumference (9% drop) was achieved.
EndoBarrier safety profile was clinically acceptable with a 1.7% event rate of hepatic abscess (4/234) and a severe bleeding rate of 0.4%. All safety-related events were resolved with no long-term complications.
This interim analysis included 234 patients. The German Registry continues to expand, and has input more than 300 patients to date.
“The data emerging from the German EndoBarrier Registry continues to support the strong efficacy and safety profile of EndoBarrier” said Scott Schorer, President & CEO of GI Dynamics. “We are encouraged by this early review, and look forward to continued clinical conclusions to be drawn from this rapidly expanding registry effort.”
“We would like to thank all participating hospitals for their contribution,” said Schorer.
The registry is supported by a grant from GI Dynamics with no access by the company to non-published or primary results. GI Dynamics has no influence on analysis of the registry results.
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 obesity. EndoBarrier is approved and commercially available in multiple countries outside the United States. EndoBarrier is not approved for sale in the United States and is limited by federal law to investigational use only in the United States. Founded in 2003, GI Dynamics is headquartered in Boston, Massachusetts. For more information, please visit www.gidynamics.com.
This 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 centers 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 consequences of terminating the ENDO trial and the possibility that future 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; and 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.
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