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.
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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