Contract with Resonance Health
This Study is expected to span 18 months and involve approximately 100 trial participants. Resonance Health's recently (December 2020) US FDA regulatory cleared HepaFat-AI(R) medical device will be used for the first time in a NASH clinical study environment to measure, grade, and quantify the liver-fat of the trial participants at two-three timepoints over the 18-month period. This is the first time HepaFat-AI(R) will be used in a third-party NASH clinical trial and is therefore a milestone in the commercialisation of this technology platform. Importantly, the use of HepaFat-AI(R) in the Study further validates the efficacy of the device and sets a precedent for other clinical trial procurement efforts by Resonance Health. The contract value is estimated to be approximately A$100K and VGI Health Technology may discontinue or extend the Study at any time in which case the Resonance Health will be paid for services performed up to the termination date or additional payments may be due for any extension of the Study.
Fatty Liver Disease - An Emerging Global Health Crisis
Fatty liver disease is emerging as a major global health issue and is attracting significant attention from international pharmaceutical companies seeking to develop effective drug treatments for the disease.
It is estimated that 24-30% of the global population suffers from Non-Alcoholic Fatty Liver Disease ("NAFLD") which roughly equates to 1.8-2.3 billion people. Of these, it is estimated that 20%, or 0.5 billion people, will also develop NASH, a severe form of NAFLD which can cause liver damage including fibrosis and cirrhosis and which often requires immediate medical intervention.
If the prevalence of NAFLD continues to rise in line with the global obesity epidemic, it is predicted that the healthcare burden of NAFLD over the next 10 years could increase to $1.005 trillion in the USA alone.
The Managing Director of Resonance Health, Mr. Mitchell Wells commented:
"We are delighted to assist Invictus with its NASH Phase II clinical study through the provision of HepaFat-AI(R) and we applaud Invictus for their efforts to find treatments for NASH. Fatty liver diseases are on the rise and Resonance Health can help combat this global epidemic with its products and services that quantify and measure fat in the liver, including HepaFat-AI(R), HepaFat-Scan(R) and LiverSmart(R). The study is a material achievement in that this is the first time HepaFat-AI(R) will be used in a NASH clinical trial, and it sets an important precedent."
The CEO and Managing Director of VGI Health Technology Limited and Director of Invictus Ops Pty Ltd., Dr. Glenn Tong commented:
"NASH is an unmet need which has presented great challenges to many drug development groups. Our NASH drug candidate, IVB001, targets multiple parts of the disease pathway including the steatosis (the accumulation of fat in the liver) which causes oxidative stress which in turn causes inflammation which results in fibrosis (the production of collagen and scarring of the liver). The partnership with Resonance Health will vastly improve the efficiency with which we measure key endpoints for this clinical study which is due to commence recruitment of patients shortly."
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.
VGI Health Technology Limited
Resonance Health Limited