GI Dynamics Announces Agreement with Apollo Sugar to Study EndoBarrier in India
November 27 2018 - 4:28PM
Business Wire
Trial to focus on reduction of hemoglobin A1c
for patients diagnosed with type 2 diabetes and obesity.
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 Sugar1 to jointly study the safety and
efficacy of EndoBarrier in India.
Apollo Sugar is a collaboration between Apollo Health &
Lifestyle Limited and Sanofi2. 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.
Forward-Looking Statements
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.
1 Apollo Sugar Clinics (apollosugar.com), a division of Apollo
Hospitals Group (apollohospitals.com)2 Sanofi (sanofi.com)
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Investor RelationsUnited States:Janell Shields+1 (781)
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