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Indian EndoBarrier study

GI Dynamics and Apollo Sugar to establish Indian EndoBarrier study

Subject to GI Dynamics raising additional capital, enrolment is expected to commence in the first half of 2019 and conclude by the end of the third quarter of 2019.

GI Dynamics entered into an agreement with Apollo Sugar to jointly study the safety and efficacy of EndoBarrier in India. The agreement between Apollo Sugar and GI Dynamics provides for the commencement of a clinical trial, pending appropriate regulatory submissions and approvals, that consists of 100 patients randomized into 75 EndoBarrier and 25 control patients with a 3-to-1 ratio. Subject to GI Dynamics raising additional capital, enrolment is expected to commence in the first half of 2019 and conclude by the end of the third quarter of 2019.

“Apollo Sugar is pleased to work with GI Dynamics to study EndoBarrier as an innovative means of treating patients diagnosed with type 2 diabetes and obesity,” said Gagan Bhalla, chief executive officer of Apollo Sugar. “Apollo Hospitals have always focused on providing advanced, safe and effective treatments to its patients. We believe EndoBarrier can provide a novel and powerful clinical tool for our clinicians, and we look forward to studying EndoBarrier in our hospitals for patients based in India and Southeast Asia.”

GI Dynamics and Apollo Sugar have agreed to work toward setting the terms of a joint partnership that will focus on the marketing, distribution and clinical support of EndoBarrier to appropriate patients throughout India and Southeast Asia. Final terms of the proposed collaboration are subject to negotiation and will be disclosed upon completion.

“We are pleased to announce this clinical trial as a first part of a partnership with Apollo Sugar to study EndoBarrier in India,” said Scott Schorer, president and chief executive officer of GI Dynamics. “We look forward to working closely with the clinical team at Apollo Sugar to first study the safety and efficacy of EndoBarrier in the region and then supply EndoBarrier to appropriate patients within the region.”

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