The pivotal trial will span 25 U.S. sites, enrolling about 500 obese patients with uncontrolled Type II diabetes and assessing changes over a period of 12 months.
The news builds on the conditional approval the FDA earlier granted for clinical studies. Data from the new ENDO trial will support GI Dynamics’ premarket approval bid for the EndoBarrier gastrointestinal liner.
The EndoBarrier device, a plastic gut-lining sleeve that hangs from the outlet of the stomach and lines the small intestine, has been studied in 12 clinical trials outside of the U.S. and has been used in more than 500 patients.
It’s designed to slow the uptake of nutrients to effect weight loss, and has been shown in small clinical trials to also mitigate the symptoms of diabetes.
The FDA in August signed off on the overall pivotal trial design using study data from outside the U.S., allowing GI Dynamics to move forward with Institutional Review Board approval while hashing out the details of the new study.
The federal watchdog agency accepted clinical data GID gathered outside the U.S., allowing the company to skip the pilot trial process and move directly to pivotal trials for EndoBarrier.
"Over the past several years, we have successfully completed extensive clinical studies and achieved several regulatory approvals outside the U.S., and it has been extremely rewarding to see the benefits EndoBarrier has brought to people living with type 2 diabetes," GI Dynamics president & CEO Stuart Randle said in prepared remarks. "We are very pleased to now have full approval in the U.S. to commence a pivotal trial of this novel therapy. We look forward to providing updates on the progress of the ENDO trial and to submitting the results for PMA approval to sell EndoBarrier in the United States."
The ability to skip the pilot trial process could represent a windfall for GI Dynamics, Randle told MassDevice.com in August.
"I think given that we’re going right into a pivotal trial, it will clearly shave time off a pathway that included a pilot," he told us. "How much [time] is unclear at this moment."
GID shares closed with a 3.7% bump on the day, trading at 56¢ per share on the Australian Stock Exchange.
EndoBarrier won CE Mark approval in the European Union in 2010 and Australian approval in 2011 for treatment of Type II diabetes and/or obesity for up to 12 months. The device is on the market in the U.K., Netherlands, Austria, Germany and Chile; GI Dynamics said it’s planning to begin sales in "a select number of new countries," including Australia, some time in 2012.