Actinogen Medical has reported initial results from the Phase II XanADu clinical trial, saying that 10mg Xanamem failed to improve cognition in patients with mild Alzheimer’s disease.
Conducted in patients suffering from mild dementia, the XanADu study did not show statistical differences in primary and secondary endpoint measures between the study drug and placebo.
However, a 10mg daily dose of Xanamem was observed to be safe and demonstrated effective inhibition of cortisol production, as determined by the expected rise in associated hormones.
Actinogen is conducting additional analysis to explore trends in the data and to find any specific cognitive domains with evident positive trends.
The Australian biotechnology company believes that higher Xanamem doses and longer treatment duration may be effective in improving cognition in Alzheimer’s patients.
Actinogen Medical CEO Dr Bill Ketelbey said: “While 10mg Xanamem was not shown to be a clinically effective dose in Alzheimer’s disease, the safety and pharmacodynamic effects observed show potential that higher doses and longer treatment duration of Xanamem may be efficacious.”
Xanamem is designed to prevent the excess production of cortisol by inhibiting the 11β-HSD1 enzyme, which is said to be concentrated in the brain areas linked to cognitive impairment in neurological disorders.
The drug’s safety and its effect on cortisol production are being studied in a clinical development programme. Initial data from these studies are anticipated to be available by the end of June this year.
The XanADu trial assessed the safety, tolerability, and efficacy of Xanamem in 186 patients with mild dementia due to Alzheimer’s disease at 25 sites in Australia, the UK, and the US.
According to the company, the Xanamem’s inhibition of cortisol production offers hope for treating cognitive impairment in neurological diseases, including Alzheimer’s and schizophrenia.
Actinogen intends to expand the drug’s development programme to include mood disorders and schizophrenia.