Patients who were re-implanted with GI Dynamics (ASX:GID) EndoBarrier intestinal liner experienced extended weight-loss and diabetes-risk improvements without additional complications, according to a new study.
A group of 19 patients who had previously undergone 1 year of EndoBarrier treatment underwent re-implantation, 14 of them for another 1-year period.
The patients lost more weight, lowered their body mass index ratings, reduced triglyceride levels and saw decreased levels of fasting blood glucose, a key blood sugar measure used to diagnose diabetes, according to a press release.
The study adds to growing evidence that the EndoBarrier system confers weight-loss benefits for patients long after removal, and adds to previous reports that re-implantation with EndoBarrier doesn’t pose new risk of procedure-related complications.
"We had demonstrated in a prior study that EndoBarrier could safely be re-implanted in patients previously treated for 1 year," investigator Dr. Alex Escalona of Pontificia Universidad Católica de Chile said in prepared remarks. "We are very pleased to see the data from this study which builds on our feasibility study and indicates that patients who have successfully completed an initial course of EndoBarrier Therapy can not only maintain a majority of their weight loss during the interim treatment period, but can also achieve additional weight loss and metabolic benefits with a second round of EndoBarrier Therapy."
GI Dynamics presented the study results during the 20th United European Gastroenterology Week in the Netherlands this week.
The EndoBarrier device is a plastic gut-lining sleeve that hangs from the outlet of the stomach and lines the small intestine. 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.
Earlier this year the FDA allowed GI Dynamics to skip pilot trials and move directly to U.S. pivotal trials on its path to the U.S. market, a move that could speed U.S. launch, CEO Stuart Randle told MassDevice.com.
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.
"I think it confirms that we ran very well-designed studies with good control and good data outside of the U.S.," Randle told us. "It makes FDA more comfortable that this is a solid data set and a solid plan and foundation."
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.
GID shares were hit hard today, down 6.6% to 57¢ by the end of the day on the Australian Exchange.