GI Dynamics discontinues ENDO trial of EndoBarrier therapy for obese patients with type 2 diabetes

GI Dynamics has announced its decision to discontinue its US pivotal clinical trial of EndoBarrier Therapy (the ENDO Trial) for the treatment of obese patients who have uncontrolled type 2 diabetes. The decision follows discussions with the the FDA regarding resumption of ENDO Trial enrollment, 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. Consistent with the company's decision, the ENDO Trial's independent Data Safety and Monitoring Board has likewise recommended stopping the ENDO Trial. 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 USA is approximately 0.73% based on experience with approximately 3,000 units shipped commercially since 2009.

GI Dynamics 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.