Enrolment hold for GI Dynamics ENDO Trial
Shares in medical device company GI Dynamics (ASX:GID) dropped by over 50% today after the US FDA placed an enrolment hold on one of its clinical trials, following four cases of infection among participants.
The ENDO Trial had been evaluating the effect of EndoBarrier Therapy, a non-surgical medical device designed to decrease blood sugar and body weight, on type 2 diabetes and obesity. The flexible, tube-shaped liner is designed to be inserted endoscopically and serve as a barrier between food and a portion of the intestinal wall.
Of the trial’s 325 subjects, four have recently contracted a bacterial infection of the liver known as hepatic abscess. While the infection is a known event related to the use of EndoBarrier, it has presented at a higher than anticipated rate in the ENDO Trial.
The FDA has therefore requested additional information to assess the risk:benefit profile of EndoBarrier in the ENDO Trial. Enrolment for the trial has been placed on hold, though monitoring of current participants will continue.
GI Dynamics believes EndoBarrier’s overall risk:barrier profile, as established from the >2900 units shipped outside the US since 2009, remains favourable. The product remains available for use in countries where it has been approved, including Australia.
The company is now working to submit the FDA’s requested information in an effort to resume enrolment.
GI Dynamics (ASX:GID) shares were trading 51.67% lower as of around 1 pm on Friday.
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