NAFLD/NASH Phase II Clinical Study
Sydney, Nov 29, 2021 AEST (ABN Newswire) - VGI Health Technology Limited (
NSX:VTL), a clinical-stage biotechnology company wth delivery platforms for improving the bioavailability and efficacy of tocotrienols (a natural product which is one part of vitamin E) and ENDRA Life Sciences Inc. (NASDAQ:NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS(R)), announced today the signing of a collaboration agreement between VGI's wholly-owned subsidiary Invictus Ops Pty Ltd and Endra to incorporate TAEUS as an add-on technology to support VGI's patient screening and biomarker measurement during the upcoming Phase II clinical study on Non-Alcoholic Fatty Liver Disease/Non-Alcoholic Steatohepatitis (NAFLD/NASH) of IVB001.
"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. By adding ENDRA's cost-effective, non-invasive TAEUS technology to VGI's protocol, we expect to deliver time and cost savings for the study through simpler, faster and non-invasive biomarker measurements of liver fat," commented ENDRA's Chairman and Chief Executive Officer Francois Michelon. "In addition, we are excited to have the opportunity to expand and strengthen our global presence into Australia, which provides further opportunity to educate care providers and patients alike regarding the importance of both detection and treatment of this condition."
"VGI is excited to incorporate ENDRA's technology into screening for our Phase II study of IVB001, which targets NAFLD/NASH," said VGI's Chief Executive Officer and Managing Director Dr Glenn Tong. "After extensive discussions between Endra and VGI, we have come to the view that there is enormous potential value in capturing data on the degree of hepatic steatosis (the build up of fat in the liver) and other biomarkers 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 naturally to explore new technologies like ENDRA's TAEUS that can lead to efficiencies in execution of our clinical studies," concluded Dr Tong.
In September 2015, a Phase Ia clinical study on IVB001 had positive topline data where all primary endpoints were achieved, 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 favourable histological changes in NAFLD/NASH and 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 public 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 product development program for evidence-based nutraceuticals and a clinical development program for prescription medicines.
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