IK+EM Study Released at EASD Shows Similar Outcomes Between Gastric Plication and EndoBarrier
September 24 2017 - 06:58PM
Business Wire
GI Dynamics®, Inc. (ASX:GID), a medical device company that has
commercialized EndoBarrier® in Europe, the Middle East and South
America for patients with type 2 diabetes and obesity, announces
that new data has been released from the Institute for Clinical and
Experimental Medications (“IK+EM”) on the comparison of 40 patients
who underwent either gastric plication or EndoBarrier treatment or
were control patients. The IK+EM released the data at the 53rd
Annual Meeting of the European Association for the Study of
Diabetes (“EASD”).
Dr. Anna Cinkajzlova, from the Centre for Experimental Medicine,
Institute for Clinical and Experimental Medicine presented
“Circulating Lipopolysaccharide and Gut Permeability in Obese
Subjects with Type 2 Diabetes: The Influence of Surgical and
Endoscopic Interventions” the analysis of which compared
gastric plication to EndoBarrier. Dr. Cinkajzlova, on behalf of the
team led by Professor Haluzik, selected 40 patients from their
registry who met the criteria to be in one of three subject groups.
Of the 40 patients, 30 had type 2 diabetes mellitus (“T2DM”) and
obesity and the remaining 10 were healthy control patients. The 30
patients with T2DM and obesity were divided into two groups of 15.
Group one underwent surgical gastric plication (“GP”) with
measurement points at baseline (treatment) and at one and
six-months post-treatment. Group two were implanted with
EndoBarrier, with measurement points at baseline (implant), and at
one month and ten months (at EndoBarrier explant).
The analysis conducted a basic science assessment of circulatory
levels of lipopolysaccharide binding protein, fatty acid binding
protein 2 and sCD14 following assigned weight-reducing treatments
combined with quantification of adipose tissue macrophages. In
addition, the study compared the clinical outcomes across multiple
health metrics and biomarkers between surgical gastric plication, a
form of gastric restriction, and EndoBarrier.
Clinical outcomes data:
EndoBarrier
Surgical
GastricPlication
month 0 month 10 month 0 month 6
implant:baseline
explant:10months
surgery:baseline
post surgery:6 months
HbA1c, % 8.7% 7.0%
7.7% 6.2% Reduction, absolute %
1.8% 1.5%
BMI (kg/m^2)
42.5 38.7 42.4
36.0 Reduction, kg/m^2
3.8 6.4
Insulin (mUI/l)
51.1
44.5 59.3 32.5 Reduction,
mUI/l 6.6 26.8
HOMA-IR 37.9 16.3
23.6 9.5 Reduction
21.6 14.1
Fasting Glucose (mmol/l)
11.7 8.1 9.2
6.7
Reduction, mmol/l
3.6 2.5 n=15
n=15 p < 0.05 p < 0.05
EndoBarrier results:
- HbA1c decreased ~1.8% from baseline,
representing a 20% reduction and 88% reduction over the 6.5%
target
- BMI decreased 3.8 kg/m2 or ~9% from
baseline
- Insulin concentrations decreased by 7.9
mUI/I or ~13% from baseline
- HOMA-IR decreased by 21.6 units or ~57%
from baseline
- Fasting glucose decreased 3.6 mmol/l or
31% from baseline
The data indicates similar outcomes between surgical gastric
plication and EndoBarrier. Reduction of systemic inflammation was
associated with both treatments as well as significant reduction of
subcutaneous adipose tissue inflammation. The study shows little
involvement in change of circulating lipopolysaccharide levels or
gut leakage in either procedure.
EndoBarrier produced superior reductions in blood sugar (HbA1c),
insulin sensitivity (HOMA-IR) and fasting glucose levels. Surgical
gastric plication produced a greater reduction in BMI and insulin
dosage than EndoBarrier.
Comparison of surgical gastric plication vs. EndoBarrier:
GP v
EndoBarrier
Comparison
Reduction Post treatment EndoBarrier vs. GP
Reduction of: EndoBarrier GP Raw % variance
HbA1c (%) 1.8% 1.5% 0.3% 4% BMI (kg/m^2) 3.8
6.4 (2.6) -6% Insulin (mUl/l) 6.6 26.8
(20.2) -37% HOMA-IR 21.6 14.1 7.5
24% Fasting Glucose (mmol/l) 3.6 2.5 1.1
9% positive variance favors EndoBarrier vs. GP
“On a basic science and mechanistic basis, both treatments (GP
and EndoBarrier) substantially improved metabolic parameters and
were associated with reduction in systemic inflammation as well as
adipose tissue inflammation,” Stated Dr. Cinkajzlova.
“In addition, it is interesting to note that GP and EndoBarrier
produced similar results despite radically different approaches. It
is important to caution that these results represent early data
from a retrospective non-randomized comparison and must be studied
further in the future,” added Dr. Cinkajzlova.
“This study is useful on many levels. It shows continued
evidence of EndoBarrier efficacy across multiple health metrics,
including standard blood sugar and weight metrics, as well as
insulin sensitivity, fasting glucose, and key inflammatory
mediators,” said Scott Schorer, president and chief executive
officer of GI Dynamics.
“The study also presents early data indicating that EndoBarrier
produces clinical efficacy that is on par with and in some cases
superior to surgical gastric plication which is a restrictive
bariatric surgery. The fact that these results can be achieved in a
minimally invasive treatment with EndoBarrier versus a full
surgical procedure is very promising,” Schorer concluded.
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. 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.
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