VGI Health Technology : NAFLD/NASH Phase II Clinical Study begins recruitment of patients

VGI Health Technology Limited

ABN: 35 111 082 485

Address: Level 45, MLC Centre, 19 Martin Place, Sydney NSW 2000

www.vgiht.com | Tel: [phone]

VGI Health Technology Limited - NAFLD/NASH Phase II

Clinical Study begins recruitment of patients

Sydney, New South Wales, 5 July 2022 - VGI Health Technology Limited is pleased to announce that its wholly owned subsidiary, Invictus Ops Pty Ltd (Invictus), has commenced recruitment of patients for its Phase II clinical study in Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic SteatoHepatitis (NASH).

The study will enrol eighty patients across eight sites in Australia, with two sites The Gallipoli Medical Research Foundation (GMRF) in Queensland and The Royal Melbourne Hospital in Victoria now commencing recruitment of patients.

This study will be 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.

Professor Darrell Crawford, the Director of Research for the GMRF, a Member of the Invictus Scientific Advisory Board and the Associate Dean, Strategic Development for the Faculty of Medicine for the University of Queensland, said "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 caused by collagen) 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 we are of the view that Invictus' transmucosal delivery platform would enhance this efficacy" commented Dr David Kingston, Invictus' Chief Scientific Officer and Chair of the Scientific Advisory Board.

Additional study sites are expected to commence recruitment of patients shortly and Invictus is advancing preparations for a Phase II clinical study in Pancreatic Adenocarcimoma (pancreatic cancer) which is expected to commence recruitment of patients later this year.

For more information please contact:
Dr Glenn Tong, CEO and Managing Director	Mrs Catriona Glover, Company Secretary
Ph: [phone]	Tel: [phone]

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VGI Health Technology Limited

About VGI Health Technology Limited

VGI Health Technology Limited trading as VGI Health Technology is an Australian public listed company (NSX:VTL). VTL refers to recent announcements about the divestment of its wholly owned subsidiary Invictus BioPharma Pty Ltd. Post completion of this transaction, VTL will be focussed on manufacturing, marketing and selling novel dietary supplements based on natural products (tocotrienols) which have wide therapeutic potential, including: Delayed Onset Muscle Soreness, muscle recovery and exercise endurance.

For more information see: https://www.vgiht.com

Investors interested in trading shares on the NSX should contact a broker who is an NSX Participant: https://www.nsx.com.au/broker_list_print.asp

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