IK+EM Study Released at EASD Shows Similar Outcomes Between Gastric Plication and EndoBarrier

LISBON, Portugal--(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 53^rd 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 Gastric Plication
	month 0	month 10	month 0	month 6
	implant: baseline	explant:10 months	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.