GI Dynamics Announces Institutional Review Board Approval for EndoBarrier Pivotal Trial
14 February 2019 - 11:44AM
Business Wire
GI Dynamics® Inc. (ASX:GID), a medical device company that is
developing EndoBarrier® for patients with type 2 diabetes and
obesity, is pleased to announce that it has received Institutional
Review Board (IRB) approval to conduct its pivotal trial of
EndoBarrier for type 2 diabetes and obesity.
As announced on 13 August 2018, the pivotal trial of
EndoBarrier, referred to as the
18-1 study, is a randomized (3:1) controlled double-blinded
clinical trial designed to measure the efficacy and safety of
EndoBarrier in conjunction with lifestyle therapy and diabetes
medication for the treatment of type 2 diabetes and obesity vs. a
sham control arm in conjunction with lifestyle therapy and diabetes
medication, also for the treatment of type 2 diabetes and obesity.
The 18-1 study will occur in two stages. Stage I consists of 50
EndoBarrier patients and approximately 17 control patients and will
be completed with the filing of four Data Monitoring Committee
(DMC) reports with the US Food and Drug Administration (FDA). Upon
review of the four DMC reports by the FDA, the company will apply
for approval to conduct Stage II of the trial, which is projected
to include the balance of patients to complete the 18-1 study total
of 240 patients (180 EndoBarrier and 60 control).
IRB approval 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 was notified
today that the following EndoBarrier pivotal trial documentation is
approved by WIRB: protocol, informed consent form, and
investigator’s brochure.
“When we announced that the FDA approved our Investigational
Device Exemption (IDE) for the pivotal trial of EndoBarrier, the
approval was conditional upon IRB approval,” said Scott Schorer,
president and chief executive officer of GI Dynamics. “This IRB
approval now satisfies that condition. In parallel, we continue to
push forward with the clinical study sites that will be part of the
18-1 study and we anticipate being in a position to announce these
clinical sites shortly.”
About GI Dynamics
GI Dynamics®, Inc. (ASX:GID) is the developer of EndoBarrier®,
the first endoscopically-delivered device therapy for the treatment
of type 2 diabetes and obesity. EndoBarrier is not approved for
sale and is limited by federal law to investigational use only.
Founded in 2003, GI Dynamics is headquartered in Boston,
Massachusetts. For more information please visit
www.gidynamics.com.
Forward-Looking Statements
This announcement may contain forward-looking statements. These
statements are based on GI Dynamics management’s current estimates
and expectations of future events as of the date of this
announcement. Furthermore, the estimates are subject to several
risks and uncertainties that could cause actual results to differ
materially and adversely from those indicated in or implied by such
forward-looking statements.
These risks and uncertainties include, but are not limited to,
risks associated with our ability to continue to operate as a going
concern; our ability to raise sufficient additional funds to
continue operations and to conduct the planned pivotal trial of
EndoBarrier in the United States (18-1 study); our ability to
execute the 18-1 study under FDA’s Investigational Device
Exemption; our ability to enlist clinical trial sites and enroll
patients in accordance with the 18-1 study; the risk that the FDA
stops the 18-1 study early as a result of the occurrence of certain
safety events or does not approve an expansion of the 18-1 study;
our ability to maintain compliance with our obligations under our
existing convertible note and warrant agreements executed with
Crystal Amber Fund Limited, including our obligations to make
payment on the relevant note that is due in March 2019; our ability
to restructure the terms of the convertible note with Crystal Amber
Fund Limited that is due in March 2019 if we are unable to raise
sufficient funds to enable us to fully repay such note when due;
obtaining and maintaining regulatory approvals required to market
and sell our products; the possibility that future clinical trials
will not be successful or confirm earlier results; the timing and
costs of clinical trials; the timing of regulatory submissions; the
timing, receipt and maintenance of regulatory approvals; the timing
and amount of other expenses; the timing and extent of third-party
reimbursement; intellectual-property risk; risks related to excess
inventory; risks related to assumptions regarding the size of the
available market; the benefits of our products; product pricing;
timing of product launches; future financial results; and other
factors, including those described in our filings with the U.S.
Securities and Exchange Commission.
Given these uncertainties, one should not place undue reliance
on these forward-looking statements. We do not assume any
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information or future events
or otherwise, unless we are required to do so by law.
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United States:Janell Shields+1 (781)
357-3280investor@gidynamics.com
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