The FDA 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.
"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," GI Dynamics CEO Stuart Randle said in prepared remarks. "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."
The pivotal trial will span 25 U.S. sites, enrolling about 500 patients with uncontrolled diabetes and assessing improvements in diabetes over a period of 12 months.
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, according to a press release.
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. It’s 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.
GI Dynamics went public in September 2011, netting nearly $80 million (A$74 million) in an initial public offering on the Australian stock exchange.
GID shares took a hit yesterday, closing at about 85¢ (0.81 AUD), a 4.7% slide.