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US EndoBarrier trial

Final efficacy and safety results of US ENDO Trial

The ENDO Trial demonstrated clinically meaningful improvements in hemoglobin A1c (HbA1c) levels and weight reduction compared with the sham-treated group
ENDO trial was discontinued in July 2015 after seven cases of hepatic abscess, an incidence rate of approximately 3.5%, which exceeds a previously established safety threshold of 2%

GI Dynamics has announced the final results of the ENDO Trial, the EndoBarrier US pivotal clinical trial. Principal investigator, Dr Lee Kaplan, presented the results at the American Diabetes Association’s (ADA) 76th Scientific Sessions in New Orleans. The ENDO Trial demonstrated clinically meaningful improvements in hemoglobin A1c (HbA1c) levels and weight reduction compared with the sham-treated group.

These efficacy outcomes were achieved with only 325 of the planned 500 subjects being randomised into the trial. The overall safety profile was positive except for the higher than anticipated rate of hepatic abscess (HA). Of note, no adverse events led to long-term sequelae or mortality.

“This study demonstrates the clinically significant efficacy of EndoBarrier Therapy for the treatment of type 2 diabetes in patients with obesity,” said principal investigator Kaplan. “While the issue of hepatic abscess needs to be addressed further, this demonstration of benefit underscores the promise of this endoluminal device.”

The trial was discontinued in July 2015 after seven cases of hepatic abscess, an incidence rate of approximately 3.5%, which exceeds a previously established safety threshold of 2%.

The decision followed discussions with the FDA regarding resumption of ENDO Trial enrolment, which despite collaborative efforts by both parties were unable to yield a feasible path forward for the mitigation of a higher than anticipated incidence of hepatic abscess, a bacterial infection of the liver. The ENDO Trial’s independent Data Safety and Monitoring Board has also recommended stopping the ENDO Trial.

“We released the initial top-line ENDO data in March 2016 and the final data were presented at the recent ADA meeting,” said Scott Schorer, president and CEO of GI Dynamics. “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. We are re-engaging with the FDA in order to work toward a revised US clinical trial and will release information about that process when it becomes available.”

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