dimecres, 28 de novembre del 2018

GI Dynamics inks deal to launch Indian EndoBarrier trial

GI Dynamics

GI Dynamics (ASX:GID) said today it inked a deal with Apollo Sugar, a collaboration between Apollo Health & Lifestyle Limited and Sanofi, to jointly launch a safety and efficacy study of the EndoBarrier system in India.

Through the deal, the groups will launch a clinical trial that aims to collect data from 100 randomized patients, with 75 receiving treatment with the EndoBarrier device and 25 serving as a control arm for the study.

“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. 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,” Apollo Sugar CEO Gagan Bhalla said in a press release.

Boston-based GI Dynamics said that it is hopeful it will launch the trial during the first half of next year and close it by the end of the third quarter. The company has not yet received regulatory approval for the trial.

“We are pleased to announce this clinical trial as a first part of a partnership with Apollo Sugar to study EndoBarrier in India. 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,” GI Dynamics prez & CEO Scott Schorer said in a prepared statement.

Both GI Dynamics and Apollo Sugar said they will negotiate a joint partnership for marketing, distribution and clinical support of the EndoBarrier system for patients in India and Southeast Asia.

Earlier this month, GI Dynamics said that it closed the second tranche of a private placement, bringing in a total of $2.8 million through the issuance of CHESS Depository Interests.

The post GI Dynamics inks deal to launch Indian EndoBarrier trial appeared first on MassDevice.



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