GI Dynamics Incorporation (ASX: GID) is into the commercialisation and development of effective non-surgical approaches for treating patients with type two diabetes and obesity. It is a medical device company that is into the development of EndoBarrier® for these patients. The company is under the health care equipment and services industry group. It is headquartered in Boston, Massachusetts, with offices in Europe and Australia.
The company on 14 February 2019, has announced to have received approval from the Institutional Review Board (IRB) to conduct its pivotal trial of EndoBarrier for type two diabetes and obesity.
As per the announcement on 13 August 2018, the pivotal trial of EndoBarrier referred to as the 18-1 study, is a randomised (3:1) controlled double-blinded clinical trial. This has been designed to measure the efficacy and safety of EndoBarrier in conjunction with lifestyle therapy and diabetes medication for the treatment of type two diabetes and obesity vs a sham control arm in conjunction with lifestyle therapy and diabetes medication, also for the treatment of type two diabetes and obesity.
The 18-1 study will occur in two stages. Stage one consists of fifty EndoBarrier patients and approximately seventeen control patients and will be completed with the filing of four Data Monitoring Committee (DMC) reports with the US Food and Drug Administration (FDA). Post review of the four DMC reports by the FDA, GI Dynamics will apply for approval to conduct stage two of the trial, which is projected to include the balance of patients to complete the 18-1 study total of 240 patients, which includes 180 EndoBarrier and 60 control patients.
The approval from the Institutional Review Board is required by the FDA and is an essential step to allow the EndoBarrier pivotal trial to proceed. Western IRB (WIRB) is serving as the company’s central IRB. GI Dynamics has been notified today (14 February 2019) that the following EndoBarrier pivotal trial documentation is approved by WIRB: protocol, informed consent form, and investigator’s brochure.
The president and chief executive officer of the company Scott Schorer said that when they announced that the FDA approved the Investigational Device Exemption (IDE) of the company for the pivotal trial of EndoBarrier, the approval was conditional upon the approval of IRB.
Moreover, he stated that the IRB approval now satisfies that condition and parallelly, the company continues to push forward with the clinical study sites that will be part of the 18-1 study, and they anticipate being able to announce these clinical sites shortly.
On the price-performance front, the stock of the company last traded at $0.018 with a market capitalisation of circa $17.26 million. The stock has yielded a negative YTD return of 5.26% and posted negative returns of 35.71% and 10.0% over the last six months and three-months period respectively. It has a 52-week high price of $0.043 with an average trading volume of 132,379. The stock is trading at a PE multiple of 0.070x with its EPS at AUD 0.246.
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