A review of interim results to follow
Conference call at 9:00 a.m. AEST on 31 July 2015 (7:00 p.m. EDT on 30 July 2015)
LEXINGTON, Massachusetts & SYDNEY, Australia – 30 July 2015 – GI Dynamics, Inc. (ASX: GID) (the Company), a medical device company that provides innovative treatments for type 2 diabetes and obesity, today announced its decision to discontinue its U.S. pivotal clinical trial of EndoBarrier Therapy (the ENDO Trial) for the treatment of obese patients who have uncontrolled type 2 diabetes.
The decision follows discussions with the U.S. Food and Drug Administration (the FDA) regarding resumption of ENDO Trial enrollment, which despite collaborative efforts by both parties were unable to yield a feasible path forward for the mitigation of a higher than anticipated incidence of hepatic abscess, a bacterial infection of the liver. The Company concluded that terminating the ENDO Trial, effective immediately, is in the best interest of all stakeholders to help ensure adequate resources to further the development of EndoBarrier for its current use and potential new indications, and to continue developing other markets for EndoBarrier Therapy. Consistent with the Company’s decision, the ENDO Trial’s independent Data Safety and Monitoring Board has likewise recommended stopping the ENDO Trial. With seven cases of hepatic abscess in the ENDO Trial, the incidence rate is approximately 3.5%, which exceeds a previously established safety threshold of 2%. The incidence of hepatic abscess in markets outside the U.S. is approximately 0.73% based on experience with approximately 3,000 units shipped commercially since 2009.
The Company will conduct a detailed review of results for the ENDO Trial and report its findings in the very near future; however, a preliminary review of available efficacy data suggests a likely outcome (>90% probability) would be a statistically significant benefit of EndoBarrier Therapy that exceeds the predefined trial endpoint for efficacy as measured by reduction of HbA1c blood sugar levels.
“Consistent with the decision to conclude the ENDO Trial, we will immediately begin explanting the device from all remaining ENDO Trial participants and closing out the ENDO Trial — a process we believe will take several months to complete — while simultaneously initiating efforts to restructure our business and costs to ensure sufficient cash remains to establish new priorities, continue limited market development and research, and evaluate strategic options,” said Michael D. Dale, president and CEO of GI Dynamics.
“We know that our decision to terminate the ENDO Trial will be a major disappointment to our patients and the clinicians who have supported the ENDO Trial, as well as our investors, but we believe that this is the responsible decision to take in the interests of all stakeholders,” said Mr. Dale.
The Company will hold an investor conference call on Friday, 31 July 2015 at 9:00 a.m. AEST (Thursday, 30 July 2015 at 7:00 p.m. EDT) to update investors regarding the ENDO Trial.
Accessing the Conference Call via Webcast:
A live webcast of the call will be available on the GI Dynamics website at investor.gidynamics.com. The webcast can be directly accessed at: http://edge.media-server.com/m/p/yzjmmc7c/lan/en.
Accessing the Conference Call via Telephone:
For those preferring to listen by telephone, please dial in five minutes prior to the start of the call and provide the passcode 99472983. Regional dial-in numbers are as follows:
- United States callers please dial toll free 1 (877) 280-1758
- Australia callers please dial toll free 1 800 005 989
- International callers please dial 1 678 562 4233
The webcast will be archived for 30 days following the call on the GI Dynamics website at investor.gidynamics.com.