The trial was approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) following the regulatory approval received from the FDA in the U.S. in January 2017.
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.
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.
Actinogen will conduct the Phase II double-blind, 12-week study to assess the safety, tolerability and efficacy of Xanamem in subjects with mild dementia due to Alzheimer’s disease.
The company will enrol 174 patients at research sites across the UK, U.S. and Australia as part of the trial.
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.
Actinogen expects to shortly receive approval from the Australian Therapeutic Goods Administration
(TGA) to conduct the trial in Australia.
This will be the last major regulatory approval required before the company can begin actively recruiting.
Actinogen’s share price has increased by more than 53% during the past three months, last trading at $0.06.
The company is well funded with a cash balance of circa $5.8 million as at 31 December 2016.