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GI Dynamics Releases Safety and Efficacy Data for EndoBarrier® Therapy

2016年05月10日 AM12:15
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LEXINGTON, Mass. & SYDNEY

GI Dynamics, Inc. (ASX:GID), a medical device company that develops innovative endoscopically delivered treatments for type 2 diabetes and obesity, announced new safety and efficacy data at the Endocrine Society’s ENDO 2016 meeting in Boston, Massachusetts.

One-year interim data from the REVISE Diabesity study – a two-year, multicenter, randomized and controlled trial – was presented by Russell Drummond, M.D., of the National Health Service (NHS) Greater Glasgow and Clyde, Scotland. The study aims to evaluate the efficacy and legacy effect of treating obese type 2 diabetes patients with EndoBarrier Therapy (EBT) plus a GLP-1 receptor agonist (liraglutide), a non-insulin medicine prescribed to lower blood sugar levels. The study’s comparison arms comprise patients treated with either liraglutide alone or EBT alone.

Data presented (below) demonstrate clinically meaningful improvements in hemoglobin A1c (HbA1c) levels and weight reduction in study subjects.

           
   

EndoBarrier
+ liraglutide
(N=24)

 

EndoBarrier
only
(N=24)

 

Liraglutide
only
(N=22)

HbA1c
(absolute
raw
values)

  HbA1c – mean baseline   9.6%   9.3%   9.7%
HbA1c reduction @ 12 mo.   2.1%   1.2%   1.3%
HbA1c @ 12 mo.   7.5%   8.1%   8.4%
  Subjects w/ < 7.5% HbA1c @ 12 mo.   54.2%   45.8%   31.8%

Weight

Weight (kg) – mean baseline   112.8   115.6   113.9
Weight loss (kg)   12.8   12.5   4.0
  Total % weight loss   11.3%   10.8%   3.5%
Dosing   Liraglutide/mg daily   1.2   n/a   1.8
   

Mean reduction in HbA1c in EndoBarrier + liraglutide arm of 2.1% represents >95% attainment of clinical target

Patients receiving EBT plus liraglutide achieved the best and most rapid improvement in their diabetes despite reducing other diabetes medications. Both EBT groups lost significantly more weight than the liraglutide-only group. The study also noted that patients in the EBT-plus-liraglutide group were administered doses of liraglutide 33 percent lower (1.2 mg) than those administered to patients in the liraglutide-only group (1.8 mg), yet the former produced significantly better results. Furthermore, in the EndoBarrier-plus-liraglutide group, six subjects (25 percent) had a reduction in diabetes medications.

EndoBarrier Therapy was found to be safe, and the combination of EBT plus liraglutide was well tolerated. All serious device-related adverse events in the EndoBarrier-treated patients, including gastrointestinal bleeding and obstruction, resolved after device removal. There was one liver abscess which did not require device removal. The abscess was resolved with antibiotics, and the patient completed the study.

The study’s chief investigator, Bob Ryder, M.D., of Sandwell and West Birmingham Hospitals NHS Trust, said, “As a clinician, it is particularly gratifying to meet patients treated with EndoBarrier Therapy and hear them report their many individual improvements in overall health.”

“Patients report considerable improvements in exercise tolerance, reductions in breathlessness, and a general sense of well-being. We also see substantial reduction in the need for other diabetes medications, particularly insulin, which is often no longer required. Usually, patients are especially pleased about this.”

Mr. Scott Schorer, president and chief executive officer of GI Dynamics, said, “This encouraging data is further clinical validation of EndoBarrier Therapy. We are delighted to see that EndoBarrier Therapy, administered alone or in combination with diabetes medication, compares favorably to treatment with pharmacotherapy.”

“The mean baseline starting HbA1c level for EBT-plus-liraglutide group was 9.6 percent. The treatment target is the reduction of HbA1c to less than 7.5 percent, which is a mean reduction greater than 2.1 percent. We were excited to see EBT-plus-liraglutide patients attain a 2.1 percent absolute reduction, which is a 95.4 percent overall attainment of target. In addition, 54.2 percent of patients attained the < 7.5 percent HbA1c treatment target.”

“This is the first study in which the combination of a GLP-1 receptor agonist and the EndoBarrier intestinal device has been used to successfully treat diabetes and obesity. The combination seems to result in the best improvements in glucose control and weight reduction,” said Piya Sen Gupta, M.D., ABCD Study research fellow at King’s College Hospital London and City Hospital Birmingham, United Kingdom.

“EndoBarrier is less invasive than surgery, achieves a similar level of bypass and can be inserted as a simple and quick outpatient endoscopic procedure that patients are likely to find more acceptable. They have one year in which to change their eating behavior; EndoBarrier helps them do this.”

Schorer added, “We will continue to support investigator-initiated studies around the world and sincerely appreciate the efforts of Dr. Bob Ryder, Dr. Piya Sen Gupta and their colleagues as they continue to expand the body of evidence supporting the use of EndoBarrier Therapy.”

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 Lexington, Massachusetts. For more information, please visit www.gidynamics.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160509006064/en/

CONTACT

Investor relations
United States:
GI Dynamics,
Inc.
James Murphy, +1 781-357-3281
Chief Financial Officer
or
Australia:
Hawkesbury
Partners Pty Limited
David Allen or John Granger, +61 2 9325 9046
or
Media
relations

United States/Europe/Australia:
+1
781-357-3250

investor@gidynamics.com
or
United
States/Australia:

WE Buchan
Catie Corcoran, +1 813-895-4575

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