GI Dynamics’ fortunes might be changing, as the embattled device maker has crossed the last hurdle in its bid for the approval of a new pivotal trial to evaluate its obesity and diabetes treatment device, the EndoBarrier.
The company recently announced it had received Institutional Review Board approval to launch a pivotal trial of the EndoBarrier. GI Dynamics has struggled significantly with the device in the past (more on that later), but until recently it has had some success.
In August of 2018, FDA gave a nod to the EndoBarrier’s pivotal trial. The last step was for the firm to secure IRB approval, which is required by FDA and is an essential step to allow the pivotal trial to proceed. Western IRB (WIRB) is serving as the company’s central IRB.
“When we announced that the FDA approved our Investigational Device Exemption (IDE) for the pivotal trial of EndoBarrier, the approval was conditional upon IRB approval,” Scott Schorer, president and CEO of GI Dynamics, said in a release. “This IRB approval now satisfies that condition. In parallel, we continue to push forward with the clinical study sites that will be part of the 18-1 study and we anticipate being in a position to announce these clinical sites shortly.”
The study, referred to as 18-1 is a randomized (3:1) controlled double-blinded clinical trial designed to measure the efficacy and safety of EndoBarrier in conjunction with lifestyle therapy and diabetes medication for the treatment of type 2 diabetes and obesity vs. a sham control arm in conjunction with lifestyle therapy and diabetes medication, also for the treatment of type 2 diabetes and obesity.
The company said the 18-1 study will occur in two stages. Stage I consists of 50 EndoBarrier patients and approximately 17 control patients and will be completed with the filing of four Data Monitoring Committee (DMC) reports with FDA.
Upon review of the four DMC reports by FDA, the company will apply for approval to conduct Stage II of the trial, which is projected to include the balance of patients to complete the 18-1 study total of 240 patients (180 EndoBarrier and 60 control).
Barriers to GI Dynamics' Success
GI Dynamics has faced significant hurdles with the EndoBarrier. In November of 2017, the company said it had received notification from its notified body SGS United Kingdom, Limited (SGS) that its CE mark was withdrawn.
In May of 2017, the company had its CE mark suspended. The company lost European approval because it needed to address nonconformance issues related to its quality management system.
The company received CE mark in 2009. Prior to losing its CE mark, FDA halted the company’s U.S. pivotal ENDO trial in 2015, after four cases of hepatic abscess were found among the 325 patients enrolled in the study. Hepatic abscess is a bacterial infection of the liver that needs immediate treatment.
After the U.S. trial was halted, GI Dynamics reduced its headcount by 48% to 36.