HREC Approval from RMH
The study will seek to enrol eighty patients across eight sites in Australia. Seven of the eight sites have already been recruited. The RMH HREC has approved VTL's study for both the RMH site and The John Hunter Hospital site in New South Wales and recruitment of patients is expected to commence in Q4 of 2021.
Dr David Kingston, VTL's Chief Scientific Officer and Chair of its Scientific Advisory Board, said "VTL's IVB001 drug candidate presents an exciting opportunity for NAFLD/NASH which at the present time has no approved treatments. What particularly interests me is the way this drug candidate targets multiple parts of the disease cascade and its delivery method which is both direct and non-invasive which is very important for chronic diseases such as NAFLD/NASH".
If left unchecked, NAFLD/NASH can progress to liver cirrhosis and liver cancer. The global market for NAFLD/NASH is expected to grow to about US$20-35B by 2025.
The study VTL will be conducting is a randomised, double-blind, placebo-controlled Phase II clinical study on NAFLD/NASH to analyse the efficacy and safety of IVB001, a drug candidate based on the non-invasive and direct delivery of tocotrienols using the Company's proprietary and patented transmucosal delivery platform.
Dr Glenn Tong, the Chief Executive Officer and Managing Director of VTL, said "We are delighted that the RMH, a widely-respected clinical research hospital closely linked to the University of Melbourne, has provided HREC approval for this Phase II clinical study. All of the VTL team are looking forward to working with the RMH to make this study a success."
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