EndoBarrier® Study in Morbidly Obese Adolescents Completes Enrollment
February 15 2017 - 3:58PM
Business Wire
- First study of EndoBarrier in
adolescents completed at University Children’s Hospital (UCH) in
Ljubljana, Slovenia
- Preliminary data show BMI reduced by 10
percent
- Acceptable safety profile and
improvement in metabolic parameters
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 that enrollment is complete
in the first clinical trial evaluating EndoBarrier in adolescents.
The study was conducted at the University Children’s Hospital (UCH)
in Ljubljana, Slovenia.
This investigator-initiated prospective single-arm study was led
by Tadej Battelino, MD, PhD, Professor of Pediatrics at UCH, and
was designed to determine the efficacy and safety of the
EndoBarrier treatment for up to one year in morbidly obese
adolescents. Preliminary data show that patients who received the
treatment saw an average of 10 percent decrease in body mass index
(BMI), metabolic improvements and no serious adverse effects.
“The preliminary data show that treatment with EndoBarrier has
the potential to treat prediabetic, severely obese adolescents,
especially those with metabolic complications,” said Dr. Battelino.
“In this study, relevant weight loss was achieved in most of the
subjects, with clinically relevant improvements in metabolic
stabilization in prediabetic patients. Our cohort also saw an
acceptable safety profile with no serious adverse events.”
Preliminary relevant metrics are reported here:
Reduction at 12 months / n = 20
Baseline
12 months
Reduction:
Mean
Reduction:
%
BMI (kg/m2) 42.5 38.2
4.3 10% Waist
circumference (cm) 127
116 11 9% HbA1c
5.3% 5.0%
0.3% 6% HOMA-IR 5.5
2.8 2.7
49% Triglycerides (mmol/l) 2.1
1.2 0.9 43%
Systolic Pressure (mmHg) 124
117 7 6%
EndoBarrier demonstrated therapeutic benefit in treating
prediabetes, as blood sugar levels (HbA1c) were reduced by 6
percent and BMI was reduced by an average of 10 percent in study
subjects. Most notable was the 49% improvement in HOMA-IR
(Homeostatic Model Assessment), a critical measure of insulin
resistance and beta-cell function. In addition, the study noted
clinically significant reductions in triglycerides (43 percent) and
systolic blood pressure (6 percent).
EndoBarrier demonstrated an acceptable safety profile, with all
study subjects completing treatment to the intended twelve-month
implant duration. No devices were removed due to adverse events;
there were no serious device-related adverse effects. Some patients
reported abdominal discomfort, mild pain, nausea and
gastrointestinal issues.
This new data confirms and adds to the preliminary analysis of
study subjects at six and twelve months that was previously
presented at the European Society for Pediatric Endocrinology
(ESPE) conference in Paris.
Obesity and its complications have a significant effect on
morbidity and mortality for adolescents. Standard treatment-based
diets and cognitive therapy have limited effects. Surgical
bariatric procedures are nonreversible and permanently alter
certain metabolic functions. The long-term consequences of those
alterations in the corporal development of adolescents are not well
known but are a source of great concern.
“Obesity in adolescents has risen to epidemic levels globally
with serious individual and public health consequences, and
long-term implications that we only have just begun to understand,”
said Scott Schorer, GI Dynamics president and CEO.
“This study, in conjunction with many additional
investigator-initiated studies around the world, is completing a
picture of clinical evidence that further reinforces the broader
safety and efficacy profile of EndoBarrier.”
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 approved
and commercially available in multiple countries outside the United
States. 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
our development and commercialization plans, potential revenues and
revenue growth, costs, excess inventory, profitability and
financial performance, ability to obtain reimbursement for our
products, clinical trials and associated regulatory submissions and
approvals, the number and location of commercial centers offering
the EndoBarrier, and our intellectual property position. 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 the consequences of
terminating the ENDO trial and the possibility that future clinical
trials will not be successful or confirm earlier results. Further
risks are associated with obtaining funding from third parties; the
timing and costs of clinical trials; the timing of regulatory
submissions; and 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 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170215006327/en/
Investor RelationsGI Dynamics, Inc.United States:Monica
Bellevue, +1 781-357-3246
Gi Dynamics (ASX:GID)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gi Dynamics (ASX:GID)
Historical Stock Chart
From Apr 2023 to Apr 2024