GI Dynamics touts preliminary Endobarrier data in adolescent prediabetes treatment

GI Dynamics (ASX:GID) today released preliminary findings from the 1st clinical trial evaluating the use of its EndoBarrier treatment for obesity in adolescents, touting a 10% decrease in BMI with no serious adverse events.

The EndoBarrier device from the Lexington, Mass.-based company is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract.

The investigator-initiated single-arm study was conducted at the University Children’s Hospital in Ljubljana, Slovenia. Data from the trial in treating prediabetes indicated 6% lower HbA1c levels and 10% reduction in BMI, with a 49% improvement in HOMA-IR. Reductions in triglycerides of 43% and systolic blood pressure of 6% were also included

GI Dynamics touted that the device demonstrated an acceptable safety profile, with all subjects completing treatment to 12-months. No devices were removed due to adverse events, and no serious device-related adverse events were reported. Some patients did report abdominal discomfort, mild pain, nausea and gastrointestinal issues.

“The preliminary data show that treatment with EndoBarrier has the potential to treat prediabetic, severely obese adolescents, especially those with metabolic complications. In this study, relevant weight loss was achieved in most of the subjects, with clinically relevant improvements in metabolic stabilization in prediabetic patients. Our cohort also saw an acceptable safety profile with no serious adverse events,” study lead Dr. Tadej Battelino said in a prepared statement.

“Obesity in adolescents has risen to epidemic levels globally with serious individual and public health consequences, and long-term implications that we only have just begun to understand. This study, in conjunction with many additional investigator-initiated studies around the world, is completing a picture of clinical evidence that further reinforces the broader safety and efficacy profile of EndoBarrier,” prez & CEO Scott Schorer said in a press release.

Earlier this month, GI Dynamics won NUB 1 reimbursement status from the German Institute for the Hospital Remuneration System for its EndoBarrier system.

This status is the highest of 4 levels, which will bring in full reimbursement for the company at the 143 participating hospitals. Payers at these hospitals will be required to cover the gaps in treatment costs for the EndoBarrier procedure, according to GI Dynamics.

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