LEXINGTON, Mass. & SYDNEY--(BUSINESS WIRE)--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 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 |
95% Bayesian 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 |
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.”
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.
Forward-Looking Statements
This announcement contains forward-looking statements concerning: our development and commercialization plans; our potential revenues and revenue growth, costs, excess inventory, profitability and financial performance; our ability to obtain reimbursement for our products; our 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 the current estimates and expectations of future events by the management of GI Dynamics, Inc. as of the date of this announcement and are subject to a number of 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; risks associated with obtaining funding from third parties; risks relating to 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, 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 risks; risks related to excess inventory; risks related to assumptions regarding the size of the available market, 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, you 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, future events or otherwise, unless required by law.
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).