Actinogen Medical (ASX: ACW) has announced TGA approval to conduct XanADu, its phase 2 clinical trial of its drug candidate, Xanamem.
The TGA approval follows similar approvals from the US FDA and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
It is the final regulatory approval required for the trial to begin actively recruiting patients in Australia, the US and the UK by early Q2 2017.
XanADu is a double-blind, 12-week, randomised, placebo-controlled study to assess the safety, tolerability and efficacy of Xanamem in subjects with mild dementia due to Alzheimer’s disease.
It will enrol 174 patients at 20 research sites across Australia, the UK and the US.
Xanamem has been specifically designed to block excess production of cortisol, the stress hormone, in the areas of the brain most affected by Alzheimer’s disease.
Raised cortisol levels have been strongly associated with Alzheimer’s disease and lowering cortisol in the brain is an important new target for treating the disease.
“We are delighted with these ongoing regulatory approvals for XanADu, as we are now finally able to start treating Alzheimer’s patients with Xanamem. New treatment options are desperately needed and XanADu is designed to demonstrate that Xanamem is an effective treatment option for this devastating disease,” said Dr Bill Ketelbey, CEO of Actinogen Medical.
Prominent Australian Alzheimer’s expert, Associate Professor Michael Woodward AM, from the Medical and Cognitive Research Unit at Austin Health in Victoria, welcomed the XanADu trial and Actinogen’s work on Xanamem.
“Novel treatment approaches are our best hope of effectively treating Alzheimer’s, so I am extremely pleased to participate in this landmark, global study of Xanamem in mild Alzheimer’s disease,” he said.
“Too many drugs are failing to show efficacy. Xanamem is different as its novel mechanism of action of inhibiting cortisol production in the brain has the potential to make a truly meaningful difference to those with Alzheimer’s. It is especially gratifying that this study is an Australian initiative and that so much of the development of Xanamem will be carried out in Australia. It’s an impressive achievement that reaffirms our ability to punch well above our weight in medical research and should make Australians proud.’’