EndoBarrier Gastrointestinal Liner: Pivotal trial data

Top-line data from the double-blind, U.S. pivotal ENDO trial in 325 inadequately controlled obese patients with Type II diabetes showed that EndoBarrier Gastrointestinal Liner missed the co-primary endpoint of reducing mean HbA1c from baseline to 12 months vs. sham control. The trial’s protocol required a statistical test to demonstrate a >96.5% probability that EndoBarrier reduced HbA1c from baseline to 12 months by >=0.4% more than the reduction in patients treated with sham. EndoBarrier reduced HbA1c from baseline to 12 months by 0.71% more than the reduction in patients treated with sham and demonstrated a 92.8% probability of reducing HbA1c by >=0.4% more than the reduction in patients treated with sham. EndoBarrier also missed the co-primary endpoint of demonstrating a >=96.5% probability that EndoBarrier led to a primary safety event incidence of <15%. Device-related serious adverse events requiring removal occurred in 11.7% of patients and demonstrated a 90.5% probability of a primary safety event incidence of <15%. The company said the “safety failure was largely due to the excess number of hepatic abscess that occurred in subjects implanted with the device.” ...