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ENDO Trial

Top-line results from the EndoBarrier’s ENDO Trial

The company plans to continue discussions with the FDA for the purpose of seeking approval of an IDE to conduct a new US clinical trial to determine the efficacy and safety of EndoBarrier using the revised clinical treatment algorithm

GI Dynamics has announced that the initial top-line results from its US pivotal clinical trial of EndoBarrier Therapy for glycaemic improvement in inadequately controlled, obese, type 2 diabetic subjects on oral anti-diabetic agents (the ENDO Trial).

In July 2015, the company terminated the ENDO Trial early due to seven cases of hepatic abscess, a bacterial infection of the liver, a number of cases that was greater than expected. Because of the early termination, only 325 of the planned 500 subjects were randomized into the trial. The smaller final sample size provides less statistical power for analyses than originally planned. Nonetheless, the pre-specified analysis methods were used to obtain the results of the ENDO Trial discussed below, based on final data collected and locked as of 3 March 2016.

Based on the initial analysis of the final dataset, the ENDO Trial demonstrated efficacy of EndoBarrier Therapy for the treatment of type 2 diabetes with an average reduction of hemoglobin A1c (HbA1c) from baseline to 12 months that was 0.71% greater with the device than with sham intervention. The effectiveness of EndoBarrier Therapy, however, did not meet the protocol-specified Primary Efficacy Endpoint criterion, a statistical test that demonstrates a greater than 96.5% probability that the change in HbA1c was at least 0.4% greater with EndoBarrier Therapy than with sham control.

The pre-specified probability criterion was 96.5%, compared with the result of 92.8%. These results are nonetheless encouraging, given that (1) the trial only enrolled two-thirds of the intended subjects; and (2) because of early suspension of the trial, data for nearly one-third of the enrolled and randomised subjects were not available for the protocol-specified primary efficacy analysis.

With respect to safety, EndoBarrier Therapy did not meet the protocol-specified Primary Safety Endpoint, defined by device-related serious adverse events (SAEs) requiring early device removal as adjudicated by an independent Clinical Events Committee. Device-related SAEs requiring removal occurred in 11.7% of subjects. However, it did not meet the protocol-specified Primary Safety Endpoint criterion, a statistical test to demonstrate the incidence of primary safety events with EndoBarrier Therapy was less than 15%. The pre-specified probability criterion was 96.5%, compared with the result of 90.5%. This safety failure was largely due to the excess number of hepatic abscess that occurred in subjects implanted with the device.

The company added that no additional cases of hepatic abscess have been identified or reported since the ENDO Trial was terminated in July 2015. All subjects with previous hepatic abscess have had complete resolution with no known clinical sequelae reported.

The company plans to submit the final report of the ENDO Trial to the FDA in April 2016, and anticipates peer-reviewed publications and presentations at scientific conferences to provide the public with a more detailed analysis of the trial data.

Although the ENDO Trial did not achieve its primary safety endpoint, evaluation of the safety data has revealed an opportunity to improve the clinical algorithm for the use of EndoBarrier Therapy. This optimised treatment algorithm is specifically designed to reduce the incidence of hepatic abscess and improve overall safety without compromising device efficacy, resulting in an improved benefit:risk profile. The revised algorithm was developed and approved by an advisory board consisting of 14 experienced EndoBarrier users, representing the fields of endocrinology, diabetology, gastroenterology, and bariatric surgery.

Based on the clinically-relevant efficacy demonstrated in the ENDO Trial, the company plans to continue discussions with the FDA for the purpose of seeking approval of an investigational device exemption to conduct a new US clinical trial to determine the efficacy and safety of EndoBarrier using the revised clinical treatment algorithm. 

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