GI Dynamics received the initial results from its pivotal clinical trial of the EndoBarrier therapy.
Here are seven points:
1. The EndoBarrier therapy is designed for glycemic improvement in inadequately controlled, obese, type 2 diabetic subjects on oral anti-diabetic agents.
2. The clinical trial, called the ENDO trial, was terminated early due to seven cases of hepatic abscess.
3. Due to the early termination, only 325 of the planned 500 subjects were randomized into the trial.
4. The ENDO trial results showed the efficacy of the EndoBarrier therapy for the treatment of type 2 diabetes. However, the therapy did not meet the protocol-specified Primary Efficacy Endpoint criterion.
5. With respect to safety, the EndoBarrier therapy did not meet the protocol-specified primary safety endpoint, defined by device-related serious adverse events.
6. The safety failure was largely due to the excess number of hepatic abscess that occurred in subjects implanted with the device.
7. The company plans to submit the final report of the ENDO trial to the FDA in April 2016.