Trial to focus on reduction of hemoglobin A1c for patients diagnosed with type 2 diabetes and obesity.
BOSTON, SYDNEY, HYDERABAD, India — 28 November 2018 — GI Dynamics Inc. (ASX: GID), a medical device company that is developing EndoBarrier for patients diagnosed with type 2 diabetes and obesity, is pleased to announce that it has entered today into an agreement with Apollo Sugar to jointly study the safety and efficacy of EndoBarrier in India.
Apollo Sugar is a collaboration between Apollo Health & Lifestyle Limited and Sanofi. Apollo Sugar is a division of Apollo Hospitals Group (Apollo) focused on the treatment of metabolic disorders and operates an integrated network of centers of excellence for diabetes, obesity and endocrinology. Apollo is the largest hospital system in India and has emerged as Asia’s foremost integrated healthcare services provider, maintaining a robust presence of hospitals, pharmacies, primary care and diagnostic clinics across the healthcare ecosystem. Since its inception, Apollo has treated over 65 million patients from 141 countries.
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, enrollment is expected to commence in the first half of 2019 and conclude by the end of the third quarter of 2019.
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.
Commenting on the collaboration, Gagan Bhalla, chief executive officer of Apollo Sugar, said, “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.”
Commenting on the collaboration, Scott Schorer, president and chief executive officer of GI Dynamics, said, “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.”
About Apollo Sugar
Apollo Sugar is an innovative, single-specialty diabetes and endocrine healthcare service provider formed as a collaboration between Apollo Health & Lifestyle and Sanofi. Recognizing the epidemic scale and complications of this disease in the region, the Apollo Hospitals Group created the Apollo Sugar model. This initiative aims to reach out to the larger population and address the ever-increasing health concerns of type 1 and type 2 diabetes, gestational diabetes and prediabetes populations with specialized and comprehensive multidisciplinary integrated care models that are personalized, intensive and proven to deliver results.
This proven model of success aims to provide patients with accessible care for diabetes and continues to expand its network across India. Apollo Sugar’s mission is to touch the lives of a million diabetic patients and make diabetes “disease free” by delivering the best outcomes via a proven, patient-centric care model that combines comprehensive clinical care with sustained lifestyle management and behavioral modification in the individual.
For more information, please visit apollosugar.com.
About GI Dynamics
GI Dynamics Inc. (ASX: GID) is the developer of EndoBarrier, an endoscopically delivered device therapy for the treatment of type 2 diabetes and obesity. EndoBarrier is not approved for sale and is limited by federal law to investigative use only. Founded in 2003, GI Dynamics is headquartered in Boston, Massachusetts. For more information, please visit gidynamics.com.
This announcement may contain forward-looking statements. These statements are based on GI Dynamics management’s current estimates and expectations of future events as of the date of this announcement. Furthermore, the estimates are subject to several 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 our ability to continue to operate as a going concern; our ability to raise sufficient additional funds to continue operations, to conduct the planned pivotal trial of EndoBarrier in the United States (GID 18-1), and to conduct the planned clinical trial of EndoBarrier in India; our ability to execute GID 18-1 under FDA IDE; our ability to enlist clinical trial sites and enroll patients in accordance with GID 18-1; the risk that the FDA stops GID 18-1 early as a result of the occurrence of certain safety events or does not approve an expansion of GID 18-1; our ability to conduct the clinical trial with Apollo Sugar in India; the risk that potential clinical issues that may occur in the Apollo Sugar trial in India affect GID 18-1 and future FDA communications; our ability to negotiate a definitive agreement for the marketing, distribution and clinical support of EndoBarrier following the completion of the proposed clinical trial in India; our ability to maintain compliance with our obligations under our existing convertible note and warrant agreements executed with Crystal Amber Fund Limited, including our obligations to make payment on the relevant notes that are due in December 2018; obtaining and maintaining regulatory approvals required to market and sell our products; the possibility that future clinical trials will not be successful or confirm earlier results; 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; the timing and extent of third-party reimbursement; intellectual-property risk; risks related to excess inventory; risks related to assumptions regarding the size of the available market; the 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, one 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 or future events or otherwise, unless we are required to do so by law.