The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract.
“This study demonstrates the clinically significant efficacy of EndoBarrier Therapy for the treatment of type 2 diabetes in patients with obesity. While the issue of hepatic abscess needs to be addressed further, this demonstration of benefit underscores the promise of this endoluminal device,” principal investigator Dr. Lee Kaplan said in a press release.
A total of 325 of the planned 50 subjects in the trial were randomized into the study, the company said, though results still showed “meaningful improvements” in HbA1c, as well as a positive overall safety profile, with exceptions for a higher than anticipated rate of hepatic abscess.
“We released the initial top-line Endo data in March 2016 and the final data were presented at the recent ADA meeting. While it was disappointing to stop the trial early, the results show clinically significant HbA1c reduction and weight loss for EndoBarrier Therapy. We are working diligently to address safety issues, most notably working toward reducing the incidence of hepatic abscess. I would like to thank the Endo trial patients, Drs. Kaplan and Buse, and all Endo trial site investigators and study coordinators for their tremendous contribution to the study of EndoBarrier Therapy. We are reengaging with the FDA in order to work toward a revised U.S. clinical trial and will release information about that process when it becomes available. In addition, we will announce a shareholder call in the near future to further explain this and other clinical data relating to EndoBarrier Therapy,” CEO Scott Schorer said in a prepared statement.
The higher-than-expected rate of hepatic abscess has been a recurring issue for the company. In May, CEO Scott Schorer said he is looking to reboot the company’s flagship EndoBarrier after a higher-than-expected rate of liver abscesses forced the halt of a clinical trial last year.
Schorer, a medical device veteran with stints as an executive or advisor at a raft of companies under his belt, told MassDevice.com that the EndoBarrier is a unique product.
The company is looking into possible causes for the hepatic abscess cases, and reviewing different clinical approaches used with the EndoBarrier treatment, to standardize best practices.
Schorer wasn’t long in the corner office in Lexington, Mass., before instituting a 30% cut to the workforce, in an effort to cut the company’s cash burn as it pursues FDA approval for the EndoBarrier. The company is also looking at the data from the halted Endo trial, and has several other studies either planned or already under way. The hepatic abscess issue is now well-known to physicians using EndoBarrier in Europe, he said.
The post GID releases final data from EndoBarrier trial appeared first on MassDevice.
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