Quarterly Update
Sydney, Jan 31, 2023 AEST (ABN Newswire) - The Directors of VGI Health Technology Limited (
NSX:VTL) are pleased to provide the following update for the quarter ending 31 December 2022.
Technological and Product Development
On 5 October 2022, VGI Health Technology Limited (NSX:VTL) announced that its wholly owned subsidiary, Invictus Ops Pty Ltd (Invictus), had commenced dosing of patients for its Phase II clinical study in Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic SteatoHepatitis (NASH). Dosing of Invictus' NAFLD/NASH drug candidate IVB001 has commenced for 1 patient at The Gallipoli Medical
Research Foundation in Queensland and 3 patients at The John Hunter Hospital in New South Wales.
A total of 80 patients will be recruited and dosed for this study which 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 Invictus' patented transmucosal delivery platform. Unlike many other Phase II clinical studies, the present study is based on efficacy signals derived from clinical studies on orally administered tocotrienols rather than animal studies and we have seen some promising results in NAFLD/NASH patients who have been administered a dietary supplement which is closely aligned to the drug candidate IVB001. This study is showing a lot of promise and we hope to be able to address the great unmet need presented by NAFLD/NASH.
On 19 December 2022, VGI Health Technology Limited announced that its wholly owned subsidiary, Invictus Ops Pty Ltd (Invictus), had now recruited and commenced dosing of 10 patients for its Phase II clinical study in Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic SteatoHepatitis (NASH).
As previously announced, total of 80 patients will be recruited and dosed for this study which 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 Invictus' patented transmucosal delivery platform. This study is currently recruiting across 6 sites in Australia: Gallipoli Medical Research Foundation in Queensland, The John Hunter Hospital and Concord Hospital in New South Wales, The Royal Melbourne Hospital in Victoria, The Royal Adelaide Hospital in South Australia and the Fiona Stanley Hospital in Western Australia.
NAFLD/NASH is a difficult and intractable disease to treat and there are currently no treatments approved by major regulatory bodies such as the Therapeutic Goods Administration here in Australia or the Food and Drug Administration in the US. Invictus' NAFLD/NASH drug candidate, IVB001, has the potential to address several aspects of this challenging disease including the steatosis (gathering of fat in liver cells), the inflammation caused by the steatosis and the fibrosis (scarring) resulting from the inflammation. There is strong evidence from clinical studies conducted by other groups on orally-delivered tocotrienols which show promising signs of efficacy against NAFLD/NASH and Invictus is of the view that its transmucosal delivery platform would enhance this efficacy.
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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