With the initiation of XanADu, we are now in the important next stage of Xanamem’s development. XanADu is a Phase-II trial to prove the effectiveness of Xanamem in patients with Alzheimer’s disease.
All the required studies to confirm that Xanamem is well tolerated with an acceptable safety profile to proceed into Phase II have been conducted. The studies also confirmed that Xanamem crosses the blood-brain-barrier in concentrations to adequately inhibit production of cortisol in the hippocampus and frontal cortex of the brain, its primary site of action.
In 2016, Actinogen Medical initiated XanADu, a Phase II efficacy and safety trial of Xanamem in patients with mild Alzheimer’s disease. XanADu is a double-blind, randomised, placebo-controlled study of 174 patients conducted at 20 sites across Australia, UK and USA. Patient recruitment and treatment commenced in 2017 with top-line results expected in early 2019. Some of the design features are provided in the table below.
Further information and updates on XanADu, can be found at Clinicaltrials.gov (identifier: NCT02727699).