GI Dynamics (Lexington, Massachusetts) attempts for regulatory approval for its EndoBarrier Gastrointestinal Liner received a much-needed boost this past week with the release results of a European weightloss study targeting the device.

The device, which is the flagship product of the company, was evaluated for its safety and efficacy for pre-surgical weight loss treatment, along with a positive effect on glucose homeostasis in morbidly obese patients with Type 2 diabetes mellitus.

Study data were published last week in the Annals of Surgery.

"The company is very pleased with these results," Stu Randale, GI Dynamics, CEO told Medical Device Daily. "The results seem to coincide with other trials that we have had in South America. This was the first European clinical weight loss study conducted with the EndoBarrier, and since then the EndoBarrier has been successfully implanted in more than 250 patients. As GI Dynamics has expanded the clinical development program for EndoBarrier in patients with obesity and Type 2 diabetes, we have continued to see impressive results."

In the most recent multi-center, randomized clinical trial, 41 patients were enrolled and 37 patients were treated. Twenty-six patients received the EndoBarrier and 11 were in the diet control group. The EndoBarrier was implanted for 12 weeks. Three patients kept the device implanted for 24 weeks. Patients in both the EndoBarrier and diet control groups followed the same diet during the study period. Starting average weight for these two groups was similar with 142.5 kg (314.2 lbs) for EndoBarrier patients versus 137.5 kg (303.2 lbs) for control group patients, and body mass index (BMI) of 48.9 vs. 49.2, respectively.

Mean excess weight loss (EWL) achieved after 12 weeks was 19.0 % for EndoBarrier patients versus 6.9 % for control patients (p<0.002). In the 3 patients that kept the EndoBarrier implanted for 24 weeks, the EWL was 24.3%. Absolute change in BMI at 12 weeks was 5.5 and 1.9 kg/m2, respectively.

Type 2 diabetes mellitus was present at baseline in 8 patients of the device group and improved in 7 patients during the 12 week study period (lower glucose levels, HbA1c and medication requirements).

Notably, 6 out of 8 patients in the device group decreased insulin dosages and/or oral anti-diabetic medication after one week. At 12 weeks, there was still an ongoing improvement in 5 patients (continuous lowering of medication requirements), and 1 patient was able to completely stop diabetes medication.

Randle said that these results help with the company's pursuit of approval in Europe, and that the company was looking forward to get CE mark approval for a six-month implantation of the device sometime next year.

He said that the company hopes to have FDA approval within the next five years, but would not give a more firm date of when the company would launch the device in the U.S.

When and if the device gains approval it enters into a plethora of treatments for Type-2 diabetes. The company says that the EndoBarrier differs because it less invasive than other treatments and is placed in the GI tract endoscopically (via the mouth) to create a barrier between food and the wall of the intestine.

The company said that this method would prevent food from coming into contact with the intestinal wall and could alter the activation of hormonal signals that originate in the intestine.

"What we're trying to mimic are the effects of a gastric bypass procedure without surgery," Randle told MDD.

A growing body of preclinical and clinical evidence supports the potential for EndoBarrier Gastrointestinal Liner to dramatically change the treatment landscape for people living with Type 2 diabetes, obese people at risk for Type 2 diabetes, and people with severe weight problems, he added.

Last summer, the company added a component to the device, the EndoBarrier Flow Restrictor, which provides an adjustable restriction at the outlet of the stomach and is designed to delay gastric emptying (Medical Device Daily, Aug. 28, 2009). The Flow Restrictor was reported to give the device a greater means of helping patients acquire weight loss.

Support for the EndoBarrier, which is poised to become a platform technology has been overwhelming, according to the company.

To date, GI Dynamics has raised more than $61 million since its inception in 2003. The company most recently closed on an additional $15 million in Series C financing (MDD, Feb. 20, 2009). With this additional funding, the company has closed on a total of $45 million in Series C financing.

Omar Ford, 404-262-5546;
omar.ford@ahcmedia.com