GI Dynamics Stops Clinical Trial Due to Safety Concerns

Lexington, Mass.-based GI Dynamics Inc., a medical device company developing technology for type 2 diabetes and obesity, is stopping its U.S. pivotal clinical trial of EndoBarrier Therapy for the treatment of obese patients who have uncontrolled type 2 diabetes.

The decision follows discussions with the U.S. Food and Drug Administration (FDA) regarding resumption of enrollment in the Endo trial. According to the company, despite collaborative efforts with the agency, they were unable to mitigate higher than anticipated incidence of hepatic abscess, a bacterial infection of the liver. The company concluded that terminating the 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,” according to a statement release by GI Dynamics.

Consistent with the company’s decision, the Endo trial’s independent data safety and monitoring board has also recommended stopping the trial. With seven cases of hepatic abscess in the trial, the incidence rate is approximately 3.5 percent, which exceeds a previously established safety threshold of 2 percent. The incidence of hepatic abscess in markets outside the United States is approximately 0.73 percent based on experience with approximately 3,000 units shipped commercially since 2009.

The company will conduct a detailed review of results for the trial and report its findings soon. A preliminary review of available efficacy data suggests a likely outcome (>90 percent 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.

“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.”

GI Dynamics is s the developer of EndoBarrier is the first endoscopically delivered device therapy approved for the treatment of obese type 2 diabetes with body mass index (BMI) greater than 30 kg/m2, or obese patients with BMI greater than 30 kg/m2 with one or more comorbidities, or obese patients with BMI greater than 35 kg/m2. The liner is indicated for a maximum implant duration of 12 months. EndoBarrier is approved and commercially available in multiple countries outside the United States, though not approved for sale in the United States, and is limited by federal law to investigational. The company was founded in 2003.