GI Dynamics Concludes ENDO Trial
30 July 2015 - 10:00PM
Business Wire
A review of interim results to
follow
Conference call at 9:00 a.m. AEST on 31 July
2015 (7:00 p.m. EDT on 30 July 2015)
GI Dynamics, Inc. (ASX: GID) (the Company), a
medical device company that provides innovative treatments for type
2 diabetes and obesity, today announced its decision to discontinue
its U.S. pivotal clinical trial of EndoBarrier Therapy (the ENDO
Trial) for the treatment of obese patients who have
uncontrolled type 2 diabetes.
The decision follows discussions with the U.S. Food and Drug
Administration (the FDA) regarding resumption of ENDO Trial
enrollment, which despite collaborative efforts by both parties
were unable to yield a feasible path forward for the mitigation of
a higher than anticipated incidence of hepatic abscess, a bacterial
infection of the liver. The Company concluded that terminating the
ENDO Trial, effective immediately, is in the best interest of all
stakeholders to help ensure adequate resources to further the
development of EndoBarrier for its current use and potential new
indications, and to continue developing other markets for
EndoBarrier Therapy. Consistent with the Company’s decision, the
ENDO Trial’s independent Data Safety and Monitoring Board has
likewise recommended stopping the ENDO Trial. With seven cases of
hepatic abscess in the ENDO Trial, the incidence rate is
approximately 3.5%, which exceeds a previously established safety
threshold of 2%. The incidence of hepatic abscess in markets
outside the U.S. is approximately 0.73% based on experience with
approximately 3,000 units shipped commercially since 2009.
The Company will conduct a detailed review of results for the
ENDO Trial and report its findings in the very near future;
however, a preliminary review of available efficacy data suggests a
likely outcome (>90% probability) would be a statistically
significant benefit of EndoBarrier Therapy that exceeds the
predefined trial endpoint for efficacy as measured by reduction of
HbA1c blood sugar levels.
“Consistent with the decision to conclude the ENDO Trial, we
will immediately begin explanting the device from all remaining
ENDO Trial participants and closing out the ENDO Trial — a process
we believe will take several months to complete — while
simultaneously initiating efforts to restructure our business and
costs to ensure sufficient cash remains to establish new
priorities, continue limited market development and research, and
evaluate strategic options,” said Michael D. Dale, president and
CEO of GI Dynamics.
“We know that our decision to terminate the ENDO Trial will be a
major disappointment to our patients and the clinicians who have
supported the ENDO Trial, as well as our investors, but we believe
that this is the responsible decision to take in the interests of
all stakeholders,” said Mr. Dale.
The Company will hold an investor conference call on Friday, 31
July 2015 at 9:00 a.m. AEST (Thursday, 30 July 2015 at 7:00 p.m.
EDT) to update investors regarding the ENDO Trial.
Accessing the Conference Call via Webcast:
A live webcast of the call will be available on the GI Dynamics
website at investor.gidynamics.com. The webcast can be directly
accessed at: http://edge.media-server.com/m/p/yzjmmc7c/lan/en.
Accessing the Conference Call via Telephone:
For those preferring to listen by telephone, please dial in five
minutes prior to the start of the call and provide the passcode
99472983. Regional dial-in numbers are as follows:
- United States callers please
dial toll free 1 (877) 280-1758
- Australia callers please dial
toll free 1 800 005 989
- International callers please
dial 1 678 562 4233
Replay archive:
The webcast will be archived for 30 days following the call on
the GI Dynamics website at investor.gidynamics.com.
About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is the developer of EndoBarrier®,
the first endoscopically-delivered device therapy approved for the
treatment of obese type 2 diabetes with BMI ≥ 30 kg/m2, or obese
patients with BMI ≥ 30 kg/m2 with ≥ 1 comorbidities, or obese
patients with BMI >35 kg/m2. The liner is indicated for a
maximum implant duration of 12 months. EndoBarrier is approved and
commercially available in multiple countries outside the U.S.
EndoBarrier is not approved for sale in the U.S. and is limited by
federal law to investigational use only in the United States.
Founded in 2003, GI Dynamics is headquartered in Lexington,
Massachusetts. For more information, please visit
www.gidynamics.com.
Forward-Looking Statements
This announcement contains forward-looking statements
concerning: our development and commercialization plans; our
potential revenues and revenue growth, costs, excess inventory,
profitability and financial performance; our ability to obtain
reimbursement for our products; our clinical trials, and associated
regulatory submissions and approvals; the number and location of
commercial centres offering the EndoBarrier®; and our intellectual
property position. These forward-looking statements are based on
the current estimates and expectations of future events by the
management of GI Dynamics, Inc. as of the date of this announcement
and are subject to a number of 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 the consequences of terminating the ENDO Trial and
the possibility that future clinical trials will not be successful
or confirm earlier results; risks associated with obtaining funding
from third parties; risks relating to 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, and the timing and extent of third-party
reimbursement; risks associated with commercial product sales,
including product performance; competition; risks related to market
acceptance of products; intellectual property risks; risks related
to excess inventory; risks related to assumptions regarding the
size of the available market, 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,
you 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, future events or otherwise, unless required by
law.
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version on businesswire.com: http://www.businesswire.com/news/home/20150730005440/en/
Investor Enquiries:United StatesGI Dynamics, Inc.Michael
Dale, +1 781-357-3310President & CEOorAustraliaHawkesbury
Partners Pty LimitedDavid Allen or John Granger, +61 2 9325
9046orMedia Enquiries:United States/Europe/Australia:Berry
& Company Public Relations LLCBill Berry, +1 212-253-8881
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