GI Dynamics gets FDA provisional nod for pivotal EndoBarrier trial

GI Dynamics (ASX:GID) has received conditional FDA approval for a pivotal clinical trial of its EndoBarrier implant in obese patients with uncontrolled Type 2 diabetes.

The US regulatory agency has agreed to accept data from clinical trials conducted outside of the US, eliminating the need to conduct a precursor pilot trial.

In granting conditional approval, the FDA has endorsed GI Dynamics' overall trial design, although some details are yet to be finalised.

GI Dynamics plans to enrol around 500 patients for the randomised, double blind, sham-controlled clinical trial, which will take place across 25 sites across the US.

The endpoints of the trial will be improvements in diabetes over an up to 12 month treatment period, including improvement in blood sugar measure HbA1c, weight loss and reduced cardiovascular risk factors.

EndoBarrier is a flexible liner designed to form a physical barrier between food and a portion of the intestinal wall, mimicking the effects of a gastric bypass. The device is administered non-surgically through the mouth, and is removed after up to 12 months of use.

As well as promoting weight loss, EndoBarrier improves blood glucose levels and influences gastrointestinal hormones linked to insulin sensitivity.

EndoBarrier has TGA approval and is available in Australia, and CE Mark approval in Europe, where it is available in markets including France, the UK and the Netherlands.

A successful US trial would pave the way for the device to be approved in Massachusetts-based GI Dynamics' home market.

GI Dynamics (ASX:GID) shares grew 5.59% in Wednesday's ASX trading, but had fallen back 4.71% to $0.810 as of around 2.30pm on Thursday in light trading.