Lexington, Massachusetts, USA and Sydney, Australia – August 22, 2012 – GI Dynamics, Inc. (Company or GI Dynamics) (ASX: GID) announced today that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to commence a pivotal clinical trial of the EndoBarrier® for the treatment of patients who have uncontrolled type 2 diabetes and are obese. The EndoBarrier is already approved and commercially available in select markets, including Chile, Australia and several countries in Europe.
“We are very pleased that the Agency has chosen to recognize the substantial amount of scientifically sound data generated from our clinical trials conducted outside the United States, allowing us to move directly into a pivotal trial,” said Stuart A. Randle, president and chief executive officer, GI Dynamics. “Going directly into a pivotal trial eliminates the need for a pilot trial and has the potential to accelerate commercialization of the EndoBarrier in the U.S. 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.”
About the Clinical Trial
Conditional approval from the FDA indicates the Agency is in agreement with the overall trial design and, while minor details are being finalized, allows the Company to move forward with the Institutional Review Board (IRB) approval process required prior to enrolling patients into the pivotal study.
The pivotal trial is a randomized, multi-center, double-blind, sham controlled trial that is expected to enroll approximately 500 people living with uncontrolled diabetes and obesity who meet the enrollment criteria at 25 sites in the United States. 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 (a key blood sugar measure for diabetes); secondary measures include weight loss and improvements in select cardiovascular risk factors, such as cholesterol.
GI Dynamics has established an Executive Committee (EC) of leaders in metabolic disease and endoscopic techniques to oversee the U.S. clinical trial. Led by Committee Chair Lee Kaplan, M.D., Ph.D., Massachusetts General Hospital, the EC also includes Louis Aronne, M.D., New York Presbyterian Hospital, Weill Cornell Medical Center; John Buse, M.D., Ph.D., University of North Carolina at Chapel Hill; and Steven Edmundowicz, M.D., F.A.S.G.E., Washington University in St. Louis.
The EndoBarrier has been studied outside the United States in 13 clinical trials and has been used in more than 500 patients. It 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.