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GI Dynamics Gets FDA Approval For EndoBarrier Pivotal Trial; Stock Up


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(RTTNews.com) - Shares of GI Dynamics Inc. (GID.AX) gained around 12 percent in Australia after the medical device company that is developing EndoBarrier for type 2 diabetes and obesity announced that it has received approval from the U.S. Food and Drug Administration or FDA for EndoBarrier Pivotal Trial.

The approval is of an investigational device exemption or IDE from the FDA to begin enrollment in a pivotal trial evaluating the safety and efficacy of EndoBarrier in the United States pending Institutional Review Board or IRB approval.

The primary endpoint of the pivotal trial is reduction in average blood sugar levels or HbA1c at 1 year. The pivotal trial will consist of randomized EndoBarrier implant and control arms; both arms will receive identical lifestyle therapy that complies with the most current American Heart Association guidelines.

The study is approved for staged enrollment, with the initial approval for treatment of up to 67 study participants. Following FDA review of the interim safety report, the company will apply for approval to expand enrollment to a planned total study population of approximately 240 participants. The FDA has recommended certain study modifications that will be submitted by the company in an IDE supplement.

Subject to securing additional financing in 2018, GI Dynamics expects to complete enrollment of Stage I of the study during the first half of 2019.


Read the original article on RTTNews (http://www.rttnews.com/2925904/gi-dynamics-gets-fda-approval-for-endobarrier-pivotal-trial-stock-up.aspx)


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