Actinogen Medical Goes to Phase II Clinical Trial After UK Approval

Actinogen Medical has recently received approval in relation to their application to conduct Phase II of their clinical trial of Xanamem™ for mild Alzheimer’s disease.

KEY TAKEAWAYS:

• The trial was approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
• XanaDu will enrol 174 patients at clinical sites across the USA, UK and Australia.
• Regulatory approval from Australia’s Therapeutic Goods Administration (TGA) is expected to follow soon.

These approvals provide a strong endorsement of Actinogen’s progress towards the treatment of Alzheimer’s and underscores the quality of Actinogen’s existing research data on Xanamem. Xanamem has been specifically designed to block the excess production of cortisol, the stress hormone, in the areas of the brain most affected by Alzheimer’s disease.

Xanamem™’s novel mechanism of action differentiates it from other Alzheimer’s drugs under development. Xanamem™ has been specifically designed to block the excess production of cortisol, the stress hormone, in the areas of the brain most affected in Alzheimer’s disease. Raised cortisol has been strongly associated with Alzheimer’s disease and lowering cortisol in the brain is an important new target for treating Alzheimer’s disease.

“Inhibiting the production of cortisol in the brain with Xanamem™ could have a major impact on the wellbeing of people living with dementia as well as those at high risk of developing this condition. I am truly excited that this study will soon be open in the UK as well as in the USA and Australia. It represents a large and critical step in the ongoing development of Xanamem™ to manage Alzheimer’s disease,” commented Professor Craig Ritchie from the University of Edinburgh.

Dr Bill Ketelbey, CEO of Actinogen Medical continued: “We are delighted with these ongoing regulatory approvals for XanADu as they represent critical milestones in the development of Xanamem™ for the treatment of Alzheimer’s disease. New treatment options are desperately needed for Alzheimer’s disease and XanADu is designed to demonstrate that Xanamem™ is an effective treatment option for this devastating disease.”

Actinogen Medical expects to shortly receive approval from the Australian Therapeutic Goods Administration (TGA) to conduct XanADu in Australia. This will be the last major regulatory approval required and the trial will begin actively recruiting patients in early Q2 2017.

1Professor Craig Ritchie is Chair of the Psychiatry of Ageing and Director of the Centre for Dementia Prevention at the University of Edinburgh, UK. He is also the National Coordinating Investigator of the UK study sites participating in XanADu, as well as the Chair of the Xanamem™ Clinical Advisory Board.

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