First Patient Enrolled in the US STEP-1 Clinical Trial of EndoBarrier at Michigan Medicine
28 January 2020 - 11:45AM
Business Wire
GI Dynamics® Inc. (ASX:GID), a medical device company that is
developing EndoBarrier® for patients with type 2 diabetes and
obesity, is pleased to announce the first patient in the United
States (U.S.) STEP-1 clinical trial has been enrolled at Michigan
Medicine in Ann Arbor, Michigan.
Michigan Medicine is one of five clinical study sites for the
STEP-1 trial; the site is led by principal investigator Allison R.
Schulman M.D., M.P.H., assistant professor of gastroenterology and
internal medicine.
“We are honored to be the first clinical study site to enroll
the first patient into the STEP-1 trial,” said Dr. Schulman. “This
groundbreaking trial is the first of its kind to measure the
primary endpoint of type 2 diabetes combined with reductions in
weight, cardiovascular risk, non-alcoholic fatty liver disease
(NAFLD), non-alcoholic steatohepatitis (NASH) and chronic kidney
disease (CKD). I am excited to help bring an interventional upper
gastrointestinal implant procedure for the treatment of multiple
metabolic disorders to this patient population.”
The STEP-1 trial is the randomized (3 EndoBarrier: 1 Control)
controlled, double-blinded pivotal trial of EndoBarrier in the U.S.
The trial is designed to measure the efficacy and safety of
EndoBarrier in conjunction with lifestyle therapy and diabetes
medication for the treatment of type 2 diabetes and obesity.
“We are constantly seeking new methodologies to treat our
growing type 2 diabetes and obesity patient population,” said Elif
A. Oral, M.D., professor of metabolism, endocrinology and diabetes
at Michigan Medicine. “EndoBarrier has shown significant promise in
previous studies by addressing high hemoglobin A1c levels and
weight as well as other metabolic syndromes, and we look forward to
gathering additional data in the STEP-1 trial.”
This is the first of 67 patients whom we expect to be enrolled
into Stage 1 of the STEP-1 trial. Regardless of what treatment arm
the patient is randomized into, all patients will receive identical
diabetes medication monitoring and counseling throughout the
24-month study period. Results from the STEP-1 trial will support
the company’s pre-market approval application for EndoBarrier to
the U.S. Food and Drug Administration (FDA).
The STEP-1 trial’s lead principal investigator is Christopher C.
Thompson M.D., M.H.E.S. of Brigham and Women’s Hospital and Harvard
Medical School in Boston, Massachusetts. The five clinical trial
sites include Brigham and Women’s Hospital, Michigan Medicine,
Baylor College of Medicine, Thomas Jefferson University and
Surgical Specialists of Louisiana.
“I have been excited about EndoBarrier since its development and
have paid close attention to the positive data that has been
released through investigator-initiated studies performed outside
of the U.S.,” said Dr. Thompson. “EndoBarrier is a unique device in
that it has been shown to produce a clinically and statistically
significant impact on type 2 diabetes and obesity as well as on a
host of metabolic comorbidities. It is a treatment option that
clearly addresses an unmet need for this disease state.”
“In addition to measuring the primary endpoint of reduction in
blood sugar at 12 months, this landmark study measures a wide
variety of metabolic conditions across a two-year period — the
first pivotal trial in the U.S. to do so,” said Scott Schorer,
president and chief executive officer of GI Dynamics. “We hope to
gather evidence to support future research of metabolic disorders
and data to support an approval in the U.S. through post-market
approval.”
The company anticipates full enrollment of the 67 patients by
the end of 2020.
About GI Dynamics
GI Dynamics®, Inc. (ASX:GID) is the developer of EndoBarrier®,
the first endoscopically-delivered medical device for the treatment
of type 2 diabetes and obesity. EndoBarrier is not approved for
sale and is limited by federal law to investigational use only.
EndoBarrier is subject to an Investigational Device Exemption by
the FDA in the United States and is conducting concurrent pivotal
trials in the United States and India. Founded in 2003, GI Dynamics
is headquartered in Boston, Massachusetts. For more information
please visit www.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 and the STEP-1 trial; our ability to execute
STEP-1 under FDA’s Investigational Device Exemption; our ability to
enlist clinical trial sites and enroll patients in accordance with
STEP-1; the risk that the FDA stops STEP-1 early as a result of the
occurrence of certain safety events or does not approve an
expansion of STEP-1; our ability to maintain compliance with our
obligations under our existing convertible notes and warrant
agreements executed with Crystal Amber, including our obligations
to make payment on the Note that is due on 31 March 2020 and our
ability to restructure the terms of the Note with Crystal Amber
that is due on 31 March 2020 if we are unable to raise sufficient
funds to enable us to fully repay such Note when due; 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.
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