Business Wire06.23.16
GI Dynamics Inc. 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, La.
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 3251 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.
“This study demonstrates the clinically significant efficacy of EndoBarrier Therapy for the treatment of type 2 diabetes in patients with obesity,” said 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.”
GI Dynamics developed 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, Mass.
References:
1. Of the 325 subjects randomized, 320 were included in the mITT analysis population.
2. Average 9.8 percent movement away from 7 percent target (i.e., increase in HbA1c).
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 3251 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 percent Bayesian Confidence Interval or p value |
||||||||||||
EndoBarrier (n=213) |
Sham (n=107) |
|||||||||||||
HbA1c |
Mean HbA1c at baseline | 8.8 ± 0.9 percent | 8.9 ± 0.9 percent | -0.1 percent | p = 0.4885 | |||||||||
Mean HbA1c change at 12 months | -1.1 ± 1.5 percent | -0.3 ± 1.6 percent | -0.8 percent | -1.17 percent, -0.35 percent | ||||||||||
Average degree of HbA1c reduction from baseline toward 7 percent target2 |
62.4 ± 91.9 percent | -9.8 ± 141.7 percent2 | 72.2 percent | p = 0.0005 | ||||||||||
Subjects with HbA1c ≤ 7 percent at 12 months (ADA target; percentage) |
34.8 percent | 9.8 percent | 25 percent | p = 0.0003 | ||||||||||
Body Weight | Mean body weight at baseline (kg) | 111.1 ± 21.5 | 111.4 ± 20.1 | -0.3 | p = 0.9170 | |||||||||
Mean body weight change at 12 months (kg) | -8.5 ± 11.1 | -2.4 ± 6.1 | -6.2 | p < 0.0001 | ||||||||||
Total body weight change at 12 months | -7.7 ± 9.6 percent | -2.1 ± 5.4 percent | -5.6 percent | p < 0.0001 | ||||||||||
Subjects who achieved total body weight loss (TBWL) ≥ 5 percent | 60.7 percent | 20 percent | 40.7 percent | p < 0.0001 | ||||||||||
Safety Endpoints | Device-related serious adverse events (SAEs) requiring early removal | 10.9 percent | n/a | n/a | 7.2 percent, 15.4 percent | |||||||||
Hepatic abscess | 3.5 percent | 0 | 3.5 percent | 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 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.”
GI Dynamics developed 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, Mass.
References:
1. Of the 325 subjects randomized, 320 were included in the mITT analysis population.
2. Average 9.8 percent movement away from 7 percent target (i.e., increase in HbA1c).