For GI Dynamics, makers of the CE-Marked EndoBarrier device therapy for obesity and type 2 diabetes, 2015 was full of challenges. The EndoBarrier device, an impermeable liner that is placed below the duodenal bulb in the first part of the small intestine, promised a minimally invasive way to achieve significant blood sugar and weight reductions.
But enrollment in the approximately 500-patient U.S. Pivotal ENDO trial being conducted on EndoBarrier was halted by FDA in March following the occurrence of hepatic abscess in four of the 325 enrolled patients. The bacterial infection of the liver was occurring at a higher rate than anticipated, management stated at the time. By July, there were a reported seven hepatic abscess cases, an incidence rate of about 3.5%, and the company announced the ENDO trial would be ended. This meant trial investigators would start removing the devices from trial patients.
The company announced a corporate restructuring in August, with plans to cut its headcount by almost 50%. One positive note: the German Diabetes Society published a statement this fall supporting use of EndoBarrier for obese patients with uncontrolled Type 2 diabetes.
The publicly traded company listed on the Australian Stock Exchange saw its stock price plummet as a result this year. Following announcement of the halted trial enrollment in early March, the stock price halved, from $0.30 to $0.15 AUD. Once management announced the trial would be ended, the stock fell further, from $0.14 to $0.04 AUD.
|Start 2016 off right by attending MD&M West, the world's largest medical design and manufacturing event, February 9-11, at the Anaheim Convention Center.|