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ENDO Trial

ENDO Trial discontinued over hepatic abscess concerns

The company will conduct a detailed review of results for the ENDO Trial and report its findings in the very near future

GI Dynamics has discontinued its US pivotal clinical trial of EndoBarrier Therapy (the ENDO Trial) for the treatment of obese patients who have uncontrolled type 2 diabetes. With seven cases of hepatic abscess in the ENDO Trial, the incidence rate is approximately 3.5%, which exceeds a previously established safety threshold of 2%. The incidence of hepatic abscess in markets outside the US is approximately 0.73%, based on experience with approximately 3,000 units shipped commercially since 2009.

The decision follows 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 company concluded that terminating the ENDO Trial, effective immediately, is in the best interest of all stakeholders to help ensure adequate resources to further the development of EndoBarrier for its current use and potential new indications, and to continue developing other markets for EndoBarrier Therapy. The ENDO Trial’s independent Data Safety and Monitoring Board has also recommended stopping the ENDO Trial.

The company will conduct a detailed review of results for the ENDO Trial and report its findings in the very near future; however, a preliminary review of available efficacy data suggests a likely outcome (>90% probability) would be a statistically significant benefit of EndoBarrier Therapy that exceeds the predefined trial endpoint for efficacy as measured by reduction of HbA1c blood sugar levels.

“Consistent with the decision to conclude the ENDO Trial, we will immediately begin explanting the device from all remaining ENDO Trial participants and closing out the ENDO Trial, a process we believe will take several months to complete, while simultaneously initiating efforts to restructure our business and costs to ensure sufficient cash remains to establish new priorities, continue limited market development and research, and evaluate strategic options,” said Michael D Dale, president and CEO of GI Dynamics. “We know that our decision to terminate the ENDO Trial will be a major disappointment to our patients and the clinicians who have supported the ENDO Trial, as well as our investors, but we believe that this is the responsible decision to take in the interests of all stakeholders.” 

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