GI Dynamics to start pivotal US trial of EndoBarrier

GI Dynamics (ASX:GID) has secured full FDA approval to conduct a pivotal clinical trial of its EndoBarrier implants in type 2 diabetes.

The company is now clear to commence the 25-site trial. The randomised, multi-centre, double-blind, sham controlled trial will involve around 500 obese patients with uncontrolled type 2 diabetes.

Results from the trial will be used to support a premarket application for EndoBarrier with the FDA.

The regulatory agency had granted provisional approval for the trial in August. Through this decision, the FDA agreed to let GI Dynamics use data from trials outside of the US to fill in for conducting a precursor pilot trial.

EndoBarrier is already approved for use in type 2 diabetes in Australia and the EU, and available for sale in Australia and parts of Europe.

EndoBarrier is a tube-shaped liner designed to be inserted orally through a non-surgical procedure. Once implanted it acts as a barrier between food and a portion of the intestinal wall in which it sits, mimicking the effects of a gastric bypass without the risks of the major surgical procedure.

The product is designed to reduce blood sugar levels, promote weight loss and improve cardiovascular risk factors including cholesterol and blood pressure.

In September, GI Dynamics arranged to set up a “centre of excellence” at St Vincent's Clinic in Sydney, which will perform implants of the device and train other surgeons in the procedure.

GI Dynamics (ASX:GID) shares were up 5c to 59c as of around 2pm on Wednesday.