First Data Derived from ABCD Worldwide EndoBarrier Registry Presented at ADA Shows Sustained Metabolic Improvements in Patien...
12 June 2017 - 12:16PM
Business Wire
- HbA1c decreased by 2% at 18 months
- Weight decreased by over 14 kg
- BMI decreased by over 5 points
- Insulin eliminated in 44% of
patients
- ABCD Worldwide EndoBarrier Registry now
has >250 entries
GI Dynamics®, Inc., (ASX:GID), a medical device company that has
commercialized EndoBarrier® in Europe for patients with type 2
diabetes and obesity, today announced data from a UK National
Health Service (NHS) EndoBarrier Registry presented
at the American Diabetes Association’s 77th Scientific
Sessions demonstrated that metabolic improvements made by patients
while implanted with EndoBarrier were sustained six months after
EndoBarrier was explanted.
The poster presentation, “Maintenance of Efficacy After
Endobarrier in UK 1st National Health Service (NHS) Endobarrier
Service,” detailed data from 12 patients in the inaugural NHS
EndoBarrier service at City Hospital in Birmingham, UK. These
patients completed a 12-month implantation of EndoBarrier and were
evaluated six months following explantation: 75 percent (9 out of
the 12) sustained considerable metabolic improvements, including
weight loss, body mass index (BMI) reduction and lower glucose
levels.
“This data from the ABCD1 Worldwide EndoBarrier Registry is from
a range of patients from our practice who remained obese and with
poor diabetes control despite all of the standard treatments,” said
Robert Ryder M.D., consulting diabetologist at City Hospital. “The
intent of this study was to evaluate the effect of EndoBarrier in a
real-world practice environment.”
“Understanding the longer-term impact of Endobarrier is
essential as we consider different metabolic interventions to
address obesity and type 2 diabetes,” said Dr. Ryder. “In addition
to sustained weight loss, BMI reduction and glucose improvement,
these patients self-reported considerable improvements in
wellbeing, energy, fitness and exercise ability. Most exciting is
that 3 of 9 patients discontinued insulin at month twelve, and the
fourth patient eliminated insulin during the 6 months post
explant.”
EndoBarrier
6 mo.
follow-up
0-12 months 18 months
implant/Baseline
explant:12 months 6 months post explant
HbA1c, % 9.7%
7.2% 7.7% Reduction,
absolute % 2.5%
-0.5%
from baseline: 2.0%
Total Body Weight, kg 117
99 102 Reduction,
kg 18
-3
from baseline: 15
BMI (kg/m^2)
42 35
36 Insulin, iU/day
104 48
10 Reduction, iU/
56 38
from baseline:
94
n=12 / insulin users: n =9
Data from 12 patients six months after the removal
of EndoBarrier demonstrates an average weight loss of more
than 14 kg from the baseline and average reduction in body mass
index (BMI kg/m2) of 5.6 points. Additionally, HbA1c levels in
patients decreased by an average 26.7 mmol/mol, or an
average of 2.0 percent from baseline levels. Nine of the 12
patients in the study were treated with insulin prior to the
implantation of EndoBarrier. At six months post-explantation, four
patients representing 44 percent of those insulin-treated patients
were able to discontinue insulin entirely.
“The team at City Hospital in Birmingham created the first NHS
service and with that service have demonstrated that
EndoBarrier is highly effective in treating patients with
refractory type 2 diabetes and obesity,” said Scott Schorer,
president and chief executive officer of GI Dynamics. “Most notable
is the durability data showing retention of much of the HbA1c
reductions despite significant reductions in median insulin usage
at months post explant from 104 iu/day to 10 iu/day.”
“In addition to strong durability data six months following the
removal of EndoBarrier, the patients themselves gave this
innovative procedure high marks. 81% of the patients would be
highly likely to recommend EndoBarrier to friends and family
members,” said Schorer.
About GI Dynamics
GI Dynamics, Inc. (ASX:GID), is the developer of EndoBarrier,
the first endoscopically-delivered device therapy approved for the
treatment of type 2 diabetes and obesity. EndoBarrier is not
approved for sale in the United States and is limited by federal
law to investigational use only in the United States. Founded in
2003, GI Dynamics is headquartered in Boston, Massachusetts. For
more information, please visit www.gidynamics.com.
Forward-Looking Statements
This announcement contains forward-looking statements concerning
the potential for EndoBarrier as an important treatment option for
patients with type 2 diabetes and obesity. These forward-looking
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 obtaining funding
from third parties; the consequences of stopping the ENDO trial and
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;
risks associated with commercial product sales, including product
performance, competition, market acceptance of products,
intellectual-property risk; risks related to excess inventory; and
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.
1 Association of British Clinical Diabetologists
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GI Dynamics, Inc.Investor RelationsUnited States:Janell
Shields, +1 781-357-3280Investor
Relationsinvestor@gidynamics.comorMedia RelationsUnited
States:Nicole Franklin, +1 617-657-1312nfranklin@jpa.com
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