ENDRA Life Sciences Expands Pharmaceutical Partnerships with VGI Health Technology to Provide TAEUS for Patient Screening and Biomarker Measurement for Phase 2 Study
November 29 2021 - 8:00AM
Business Wire
VGI’s Upcoming
Phase 2 NAFLD-NASH study to incorporate ENDRA’s TAEUS technology to
help drive trial efficiencies
ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of
Thermo Acoustic Enhanced UltraSound (TAEUS®), and VGI Health
Technology Limited (NSX: VTL), a clinical-stage biotechnology
company specializing in developing and commercializing
evidence-based nutraceuticals and pharmaceuticals, announce today
the signing of a collaboration agreement to incorporate ENDRA’s
proprietary TAEUS technology to support patient screening and
biomarker measurement during VGI’s upcoming Phase 2 study of IVB001
in Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic
Steatohepatitis (NASH).
"We are delighted to partner with VGI to help advance the
clinical development of IVB001. It’s clear that pharmaceutical
companies and contract research organizations driving the
NAFLD-NASH therapy pipeline face the same hepatic steatosis
measurement challenges using MRI and liver biopsy as end-user
clinicians face. By adding ENDRA’s cost-effective, non-invasive
TAEUS technology to VGI’s clinical trial protocol, we expect to
deliver time and cost savings through simpler, faster and
non-invasive biomarker measurements of liver fat,” commented
ENDRA's Chief Executive Officer Francois Michelon. “In addition, we
are excited to expand and strengthen our global presence into
Australia, which provides further opportunity to educate care
providers and patients alike regarding the importance of detection
and treatment of this condition.”
“We are excited to incorporate ENDRA’s technology in our Phase 2
study of IVB001 in NAFLD-NASH,” said VGI’s Chief Executive Officer
and Managing Director Glenn Tong, Ph.D. “There is enormous
potential value in capturing data on the degree of hepatic
steatosis and other biomarkers at the front-end, and throughout the
study, to refine our understanding of systemic variables associated
with NAFLD-NASH. We believe ENDRA’s TAEUS system is uniquely
designed to accomplish this task for us. VGI’s focus on innovation
leads us to explore new technologies like TAEUS that can drive
efficiencies in the execution of our clinical studies.”
In September 2015 a Phase 1a clinical study with IVB001 met all
primary endpoints including confirmation of the bioavailability of
the compound with good plasma levels, dose relationship and
duration of plasma levels achieved. Research from a number of
groups using orally delivered tocotrienols to treat NAFLD-NASH have
shown promising results in improving liver function and bringing
about favorable histological changes in NAFLD-NASH. This points to
transmucosally delivered tocotrienols like VGI’s IVB001 having
great potential to address this intractable disease where there is
no approved treatment.
About VGI Health Technology Limited
VGI Health Technology Limited (NSX:VTL) is an Australian
publicly listed biotechnology company developing and
commercialising novel dietary supplements and prescription
medicines based on natural products (tocotrienols) which have wide
therapeutic potential, including: Delayed Onset Muscle Soreness,
muscle recovery, exercise endurance, Non-Alcoholic Fatty Liver
Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH), pancreatic
cancer, hyperlipidaemia, hypertension and diabetes. VTL owns and
controls patent and other intellectual property rights for novel
approaches to non-invasively delivering tocotrienols directly to
the target tissues. The Company has a clinical development program
for prescription medicines and a product development program for
evidence-based nutraceuticals. For more information see:
www.vgiht.com.
About ENDRA Life Sciences Inc.
ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced
UltraSound (TAEUS®), a ground-breaking technology being developed
to visualize tissue like MRI, but at 1/50th the cost and at the
point of patient care. TAEUS® is designed to work in concert with
400,000 cart-based ultrasound systems in use globally today. TAEUS®
is initially focused on the measurement of fat in the liver as a
means to assess and monitor Non-Alcoholic Fatty Liver Disease
(NAFLD) and Non-Alcoholic Steatohepatitis (NASH), chronic liver
conditions that affect over one billion people globally, and for
which there are no practical diagnostic tools. Beyond the liver,
ENDRA is exploring several other clinical applications of TAEUS®,
including visualization of tissue temperature during energy-based
surgical procedures. For more information, please visit
www.endrainc.com.
Forward-Looking Statements
All statements in this release that are not based on historical
fact are "forward-looking statements" within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Forward-looking statements, which are based
on certain assumptions and describe our future plans, strategies
and expectations, can generally be identified by the use of
forward-looking terms such as "believe," "expect," "may," "will,"
"should," "could," "seek," "intend," "plan," "goal," "estimate,"
"anticipate" or other comparable terms. Examples of forward-looking
statements include, among others, estimates of the timing of future
events and achievements, such as the expectations regarding
milestones and future sales, our 510(k) submission with the FDA and
commercializing the TAEUS® device; and expectations concerning
ENDRA's business strategy. Forward-looking statements involve
inherent risks and uncertainties which could cause actual results
to differ materially from those in the forward-looking statements,
as a result of various factors including, among others, our ability
to develop a commercially feasible technology; receipt of necessary
regulatory approvals; the impact of COVID-19 on our business plans;
our ability to find and maintain development partners, market
acceptance of our technology, the amount and nature of competition
in our industry; our ability to protect our intellectual property;
and the other risks and uncertainties described in ENDRA's filings
with the Securities and Exchange Commission. The forward-looking
statements made in this release speak only as of the date of this
release, and ENDRA assumes no obligation to update any such
forward-looking statements to reflect actual results or changes in
expectations, except as otherwise required by law.
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Company Contact: Irina Pestrikova Senior Director,
Finance investors@endrainc.com www.endrainc.com Investor
Relations Contact: Yvonne Briggs LHA Investor Relations (310)
691-7100 ybriggs@lhai.com VGI Health Technology Investor
Relations Contact: Dr. Glenn Tong CEO and Managing Director
Phone +61 412 193 350 glenn.tong@vgiht.com
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