Over a year since the discontinuation of its US study, GI Dynamics, Inc., says it has demonstrated clinical benefit in a German registry.
Remember EndoBarrier, the innovative device to improve outcomes for patients diagnosed with type 2 diabetes and obesity that resembles a sleeve, insertable into the duodenum? In July 2015 we reported the news that the US pivotal study that could have presaged approval in the country, was being terminated due to a higher than predicted rate of hepatic abscess. The sad truth at the time was that outside the U.S. the incidence of hepatic abscess in the treated population was only 0.73%, far lower than the 3.5% reported in the ENDO study. As we said at the time, what was behind the high level of hepatic abscess was unclear, and the sad fact was that available efficacy data at the time predicted a likely outcome of a statistically significant benefit of EndoBarrier Therapy, exceeding the predefined trial endpoint for efficacy as measured by reduction of HbA1c blood sugar levels.
Last month the device received more bad news in the form of a delisting by Australian regulator (TGA), restricting its use to approved trials.
Jump forward to this week and we find The German EndoBarrier registry, which is run at the University Hospital Hamburg-Eppendorf (UKE), has released positive data at the EASD (European Association for the Study of Diabetes).
Dr Nina Riedel of UKE presented data from 234 patients at the EASD in Munich, Germany. The EndoBarrier produced clinically relevant results, lowering absolute HbA1c mean from 8.5% to 7.2%. This occurred in concert with a lowering of antidiabetic medication in 78% of patients, and reducing the injected dose of Insulin by 42% on a mean basis.
Excess weight also dropped by a mean of 15kg, which represented a 29% drop in excess weight. In addition, a mean drop of 10cm waist circumference (9% drop) was achieved.
EndoBarrier safety profile was clinically acceptable with a 1.7% event rate of hepatic abscess (4/234) and a severe bleeding rate of 0.4%. All safety-related events were resolved with no long-term complications.
The German Registry continues to expand, and has input more than 300 patients to date, with this interim analysis including 234 patients.
Importantly, while the registry is supported by a grant from GI Dynamics, the company has no access to non-published or primary results, nor any influence on analysis of the registry results.
Dr. Riedel said, “Patients significantly benefitted from improvement of HbA1c, reduction of antidiabetic medication, reduction of weight and were able to improve obesity-associated comorbidities.”
“The data emerging from the German EndoBarrier Registry continues to support the strong efficacy and safety profile of EndoBarrier” said Scott Schorer, President & CEO of GI Dynamics. “We are encouraged by this early review, and look forward to continued clinical conclusions to be drawn from this rapidly expanding registry effort.”
“We would like to thank all participating hospitals for their contribution,” said Schorer.
Source: Business Wire