GI Dynamics (ASX:GID) said a retrospective study of its EndoBarrier device for patients with type 2 diabetes and obesity shows a significant reduction in HbA1c, weight, liver fat and cardiovascular disease (CVD) risks as well as a reduction in the need for insulin in some patients.
The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract, according to the Lexington, Mass.-based company.
The study by the U.K.’s National Health Service (NHS) is based on data collected from the first implant in October 2014 to the last explant in November 2018. Results were released at the recent Diabetes UK Professional Conference 2019 in Liverpool.
The primary outcome of HbA1c, weight, CVD risk factors and alanine aminotransferase (ALT — a liver fat measure) show a significant reduction at explant compared to baseline values. Of the 61 patients studied, 35 were on insulin prior to treatment. At explant, 10 of the 35 (28.6%) discontinued their use of insulin. The most significant outcome measure is the 2.2 absolute percent reduction of HbA1c at 12 months with a concurrent weight loss of 35 lbs.
Further analysis of the data using the U.K. Prospective Diabetes Study risk engine led principal investigator Dr. Robert Ryder of Sandwell and West Birmingham hospitals to hypothesize that approximately 8 of 100 patients who have EndoBarrier implanted would avoid coronary heart disease or a stroke over the next 10 years.
“We are pleased to share the final outcome from this study, which suggests EndoBarrier can provide significant improvements for patients with long-standing poorly controlled diabetes and obesity, who have been unable to manage their diabetes with standard treatment options,” Ryder said in a prepared statement. “Further evidence and research suggest EndoBarrier contributes to the reduction of other comorbidities associated with type 2 diabetes and obesity.”
“This expanded data set from the NHS EndoBarrier service continues to develop the breadth of support for clinical efficacy of EndoBarrier in a real-world clinical setting,” added GI Dynamics’ president & CEO Scott Schorer. “The significant reduction of HbA1c, weight and improvement in numerous markers — including reduction in cardiovascular risk and elimination of insulin use for 28 percent of patients — is substantial.”
GI Dynamics won Institutional Review Board approval to launch a pivotal trial of EndoBarrier in the U.S. last month. The approval, which follows FDA approval it won last August, is a boon for the company, which has faced a number of hurdles with its device over the past few years, including shutting down an initial FDA-approved study, being pulled off the shelves in Australia and losing its CE Mark approval in the European Union.
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