GI Dynamics has won a nod from FDA to begin a pivotal trial of the embattled EndoBarrier, a technology used to treat patients with type 2 diabetes. The pivotal trial could be a significant turning point in the life of the Lexington, MA-based company, which was founded in 2004.
The firm has been approved for staged enrollment with initial approval for treatment of up to 67 study participants including 50 EndoBarrier and about 17 control participants. GI Dynamics said it expects to complete enrollment of Stage I of the study during the first half of 2019.
“This IDE approval is the result of more than two years of scientific investigation and research focused on clinical trial design in collaboration with FDA, with the intent of designing a robust pivotal trial focused on the treatment of type 2 diabetes,” Scott Schorer, president and CEO of GI Dynamics said in a release. “EndoBarrier remains one of the few technologies focused on the primary target of achieving glycemic control for patients diagnosed with type 2 diabetes that is not bariatric/metabolic surgery or anti-diabetes medication.”
The EndoBarrier creates a barrier between food and the wall of the small intestine and thereby changes metabolic pathways by controlling how food moves through the digestive system. The effects are supposed to be similar to gastric bypass surgery, but without the surgical procedure and hospital stay.
The idea behind the device is that preventing food from coming into contact with the intestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery.
While the idea behind the EndoBarrier might be a novel one, the device has been plagued with significant issues over the years that have hindered its approval. In fact, GI Dynamics problems were part of the seven key moments MD+DI identified that transformed the obesity device market.
Here’s a quick recap:
In March 2015, FDA halted the company's U.S. pivotal ENDO trial after four cases of hepatic abscess were found among the 325 patients enrolled in the trial. Hepatic abscess is a bacterial infection of the liver that needs immediate treatment. The company had to cut its headcount by 48% to 36 in 2015 after the U.S. trial was halted. Prior to that, GI Dynamics had to stop shipment for a while in late 2014 and received an advertising complaint in Australia.
Last year, GI Dynamics lost its right to sell the End Barrier in the European Union under a CE mark. The company first received word in May of 2017 that its CE mark was being suspended pending resolution of nonconformances related to ISO 13485 compliance. GE Dynamics said it has been working to address the issues raised by SGS.
GI Dynamics had been quiet for a while, but the firm started making noise back in March, when shareholders approved an offering of $2 million. Because of the shareholder measure, MD+DI asked the question was GI Dynamics being positioned for a comeback?