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Trial approval

FDA approves pivotal clinical trial design for EndoBarrier

FDA gives conditional approval to trial design
500 patients to be enrolled at 25 sites in the US
Endobarrier Gastrointestinal Liner

GI Dynamics has received conditional approval from the FDA to begin a pivotal clinical trial of the EndoBarrier Gastrointestinal Liner for the treatment of patients who have uncontrolled type 2 diabetes and are obese.

The EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. Once implanted, the EndoBarrier has been shown to affect certain gastrointestinal hormones involved in insulin sensitivity, glucose metabolism and satiety, and these changes allow for rapid and sustained improvement of type 2 diabetes and weight loss.

The device has been studied outside the US in 13 clinical trials and has been used in more than 500 patients. The EndoBarrier is already approved and commercially available in select markets, including Chile, Australia and several countries in Europe.

The pivotal trial is a randomised, multi-centre, double-blind, sham controlled trial that is expected to enrol approximately 500 people living with uncontrolled diabetes and obesity who meet the enrolment criteria at 25 sites in the US. The trial is designed to assess improvements in diabetes over a treatment period of up to 12 months.

The primary endpoint of the trial is improvement in HbA1c; secondary measures include weight loss and improvements in select cardiovascular risk factors, such as cholesterol.

Conditional approval indicates that the FDA is in agreement with the overall trial design and, while minor details are being finalised, its allows the company to move forward with the Institutional Review Board approval process required prior to enrolling patients into the pivotal study.

“We are very pleased that the FDA has chosen to recognise the substantial amount of scientifically sound data generated from our clinical trials conducted outside the US, allowing us to move directly into a pivotal trial,” said Stuart A Randle, president and chief executive officer of the company. “Going directly into a pivotal trial eliminates the need for a pilot trial and has the potential to accelerate commercialisation of the EndoBarrier in the US. We look forward to continuing to work with the Agency to finalize the remaining details of the study and expect to initiate the trial before the end of the year.”

GI Dynamics has established an Executive Committee of leaders in metabolic disease and endoscopic techniques to oversee the US clinical trial.

Led by Committee Chair Dr Lee Kaplan (Massachusetts General Hospital) the Executive Committee also includes Drs Louis Aronne (NewYork Presbyterian Hospital, Weill Cornell Medical Center), John Buse (University of North Carolina at Chapel Hill) and Steven Edmundowicz (Washington University, St Louis).

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