GI Dynamics announced the final results of its ENDO Trial, the clinical trial for its EndoBarrier therapy in the United States.
The EndoBarrier therapy is designed for glycemic improvement in inadequately controlled, obese, type 2 diabetic subjects on oral anti-diabetic agents. GI Dynamics terminated the trial early, , however, due to seven cases of hepatic abscess.
Here are three notes:
1. The ENDO Trial demonstrated clinically meaningful improvements in hemoglobin A1c levels and weight reduction compared with the sham-treated group.
2. However, the therapy did not meet the protocol-specified Primary Efficacy Endpoint criterion or the protocol-specified primary safety endpoint with respect to safety, according to initial results of the ENDO trial released in March.
3. Principal investigator, Lee Kaplan, MD, PhD, presented the results at the American Diabetes Association's 76th Scientific Sessions in New Orleans.
"We released the initial top-line ENDO data in March 2016 and the final data were presented at the recent ADA meeting. While it was disappointing to stop the trial early, the results show clinically significant HbA1c reduction and weight loss for EndoBarrier Therapy.," said Scott Schorer, president and CEO of GI Dynamics, in a statement. "We are working diligently to address safety issues, most notably working toward reducing the incidence of hepatic abscess."