By OMAR FORD
Medical Device Daily Staff Writer
Perhaps the words, "It's been a long time coming", which happen to also comprise much of the chorus for an old Sam Cooke song, are appropriate when describing the latest news coming out of GI Dynamics (Lexington, Massachusetts) this week. The med-tech firm, which has been relatively quiet over the last few months, reported on Thursday that it had received FDA conditional approval for a pivotal clinical trial for the EndoBarrier Gastrointestinal Liner. The FDA's measure is an important milestone in the continued development of the product, the company said.
The pivotal trial will focus on the treatment of patients who have uncontrolled Type 2 diabetes and are obese.
"There's extraordinary excitement in the company," Stuart Randle president/CEO of GI Dynamics, told Medical Device Daily. "This has been something we've been working on for a long time and it's a huge milestone for us . . . and the opportunity to go right into this study in the U.S. is something we see as a big win for us inside the company as well as a big win for patients and physicians in the U.S., who will now get access to this . . . technology."
The pivotal trial is a randomized, multi-center, double-blind, sham-controlled trial that is expected to enroll about 500 people living with uncontrolled diabetes and obesity who meet the enrollment criteria at 25 sites in the U.S. The trial is designed to assess improvements in diabetes over a treatment period of up to 12 months.
"The study is designed with the primary endpoint improvement of HbA1c in obese adult populations," he said. "Like many of our other previous studies our primary objective is to show improvement of diabetes conditions in an obese population. We also, in the study, have secondary endpoints in weight loss as well as cardiovascular factors like cholesterol."
Conditional approval from the FDA for the trial 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.
GI Dynamics remained tight lipped when it came to discussing a potential timeline for when it hoped to have approval.
"We're most excited about the fact that this decision helps us to go directly into the pivotal trial, which will certainly accelerate any of the previous times we had," he said. "We're still working with FDA on final approval; working with the sites on the timeline; working with the different firms to help us accelerate enrollment and the implementation of the study. I would like to also work with FDA once the study is completed to possibly see how we might possibly accelerate the timeline between finishing the study and having a panel meeting. There are a number of variables there and we're just starting to talk to FDA about those now."
The EndoBarrier is placed in the GI tract endoscopically (via the mouth) to create a barrier between food and the wall of the intestine. Physicians believe that preventing food from coming into contact with the intestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery. It has been studied outside the U.S. in 13 clinical trials and has been used in more than 500 patients. The device received CE mark approval nearly three years ago (Medical Device Daily, Dec. 23, 2009).
"We are CE marked in [some parts of] Europe for Type 2 Diabetes and or obesity," Randle told MDD. "So that very broad label allows us to market quite broadly. Our commercial activity before has been in a very focused manner working with individual centers. Feedback from physicians and patients has been outstanding."
If the company manages to gain FDA approval then there a whole new world of possibilities that the device could be used for, Randle said. The device also has the potential to impact a tremendous market in the U.S.
Estimates indicate that Type 2 diabetes affects more than 23 million people in the U.S. and about 320 million people worldwide. Type 2 diabetes, which accounts for about 90% of all cases of diabetes, occurs when the pancreas has reduced effectiveness in insulin production associated with an increase in insulin resistance. The diagnosis of Type 2 diabetes usually occurs after the age of 40 and is often, but not always, associated with obesity.
"This product and technology can really offer a platform of products," he said. "We can contemplate studies in the future whereby we would go potentially more toward weight loss indications or any other indications based on the results from this first study."
Omar Ford; 404-262-5546;
Published August 24, 2012