|The EndoBarrier in the intestine--Courtesy of GI Dynamics|
The U.S. Food and Drug Administration has placed a hold on enrollment in the ongoing U.S. pivotal trial for the EndoBarrier. The device is a gastric liner from GI Dynamics that is intended to inhibit the absorption of nutrients, thereby providing weight loss and addressing obesity and Type 2 diabetes.
The FDA hold was due to four cases of bacterial infection of the liver, or hepatic abscess, in the 325 trial subject population. This is a known adverse event related to use of the EndoBarrier--but it presented at higher rates than expected in the trial. The company had set relative thresholds for an anticipated incident rate of hepatic abscess in the trial; the incident with the fourth patient exceeded that and triggered an analysis.
On a conference call, GI Dynamics' President and CEO Michael Dale said the infections are "likely related to the anchoring system interacting with the duodenum."
The EndoBarrier is a flexible, tube-shaped liner that is inserted endoscopically and placed at the beginning of the small intestine for up to one year. After that, it's removed during another endoscopic procedure.
Of the more than 2,900 commercial EndoBarrier units shipped outside the U.S. since 2009, about 1% of these have been implicated in hepatic abscess cases. Enrolled patients in the trial will continue to be the subject of data collection in the trial that's been put on hold. Patients presenting with bacterial infection due to the EndoBarrier typically have the device removed and are treated with antibiotics to resolve the infection.
The company said it has implemented "several risk mitigation strategies" in the pivotal trial and is working with the FDA toward resuming enrollment.
Dale said the company is "expeditiously working to submit additional risk/benefit information as requested by the FDA to resume the trial as quickly as possible."
Already a penny stock, GI Dynamics shares were cut in half on the trial hold news to $0.15.
- here is the release