It’s a disastrous situation for device company GI Dynamics, Inc., which is to discontinue its U.S. pivotal clinical trial of EndoBarrier Therapy (the ENDO Trial) for the treatment of obese patients who have uncontrolled type 2 diabetes.
The decision to terminate the ENDO trial comes as the inevitable consequence of the company and the FDA struggling to find a common position in the wake of the trial yielding a higher than predicted rate of hepatic abscess. The parties failed to agree on the resumption of 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.
So here they sit, staring dejectedly at the ashes of a product that had been doing rather well outside the U.S. Indeed the incidence of hepatic abscess in the treated population (3000 units sold OUS thus far) was only 0.73%, far lower than the 3.5% reported in the ENDO study.
GI Dynamics was no doubt highly reluctant to terminate the study, but says it did so having concluded that it’s “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.
Quite what’s behind the high level of hepatic abscess is unclear, but perhaps saddest is the fact that 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.
The Company says it will hold an investor conference call today to update investors regarding the ENDO Trial.
“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,” said Mr. Dale.
Source: GI Dynamics, Inc.