Final Efficacy and Safety Results of U.S. ENDO Trial Announced at ADA

  • Statistically and clinically significant efficacy: 1.1% absolute reduction in HbA1c
  • Statistically and clinically significant efficacy: 7.7% reduction in body weight
  • 34.8% of patients achieved the ADA target of HbA1c ≤ 7.0% after 12 months

LEXINGTON, MASS. AND SYDNEY, AUSTRALIA23 June 2016 – GI Dynamics, Inc. (ASX: GID), a medical device company that has developed an innovative endoscopically delivered treatment for type 2 diabetes and obesity, today announced the final results of the ENDO Trial, the EndoBarrier U.S. pivotal clinical trial. Principal investigator, Lee Kaplan, M.D., Ph.D., presented the results at the American Diabetes Association’s (ADA) 76th Scientific Sessions in New Orleans.

The ENDO Trial demonstrated clinically meaningful improvements in hemoglobin A1c (HbA1c) levels and weight reduction compared with the sham-treated group. These efficacy outcomes were achieved with only 325[1] of the planned 500 subjects being randomized into the trial. The overall safety profile was positive except for the higher than anticipated rate of hepatic abscess (HA). Of note, no adverse events led to long-term sequelae or mortality.

 

mITT Population1
Mean Difference (Endo-Sham)
95% Bayesian Confidence Interval or
p value
EndoBarrier
(n=213)
Sham
(n=107)
 
 
 
HbA1c
Mean HbA1c @ baseline
8.8 ± 0.9%
8.9 ± 0.9%
-0.1%
p = 0.4885
Mean HbA1c change @ 12 months
-1.1 ± 1.5% 
-0.3 ± 1.6%
-0.8%
-1.17%, -0.35% 
Average degree of HbA1c reduction from baseline toward 7.0% target[2]
62.4 ± 91.9%
-9.8 ± 141.7%2
72.2%
p = 0.0005
Subjects with HbA1c ≤ 7.0% @ 12 months
(ADA target; %)
34.8% 
9.8%
25.0%
p = 0.0003 
Body Weight
Mean body weight @ baseline (kg)
111.1 ± 21.5 
111.4 ± 20.1
-0.3 
p = 0.9170
Mean body weight change @ 12 months (kg)
-8.5 ± 11.1
-2.4 ± 6.1
-6.2
p < 0.0001 
Total body weight change @ 12 months
-7.7 ± 9.6% 
-2.1 ± 5.4%
-5.6%
p < 0.0001 
Subjects who achieved total body weight loss (TBWL) ≥ 5%
60.7% 
20.0%
40.7%
p < 0.0001 
Safety Endpoints
Device-related serious adverse events (SAEs) requiring early removal
10.9%
n/a
n/a 
7.2%, 15.4%
Hepatic abscess
3.5%
0
3.5% 
n/a
Other
No mortality or long-term sequelae

“This study demonstrates the clinically significant efficacy of EndoBarrier Therapy for the treatment of type 2 diabetes in patients with obesity,” said principal investigator Dr. Kaplan. “While the issue of hepatic abscess needs to be addressed further, this demonstration of benefit underscores the promise of this endoluminal device.”

Scott Schorer, president and CEO of GI Dynamics, said, “We released the initial top-line ENDO data in March 2016 and the final data were presented at the recent ADA meeting. While it was disappointing to stop the trial early, the results show clinically significant HbA1c reduction and weight loss for EndoBarrier Therapy. We are working diligently to address safety issues, most notably working toward reducing the incidence of hepatic abscess.

“I would like to thank the ENDO Trial patients, Drs. Kaplan and Buse, and all ENDO Trial site investigators and study coordinators for their tremendous contribution to the study of EndoBarrier Therapy.

“We are reengaging with the FDA in order to work toward a revised U.S. clinical trial and will release information about that process when it becomes available. In addition, we will announce a shareholder call in the near future to further explain this and other clinical data relating to EndoBarrier Therapy.”

[1] Of the 325 subjects randomized, 320 were included in the mITT analysis population.

[2] Average 9.8% movement away from 7.0% target (i.e., increase in HbA1c).