Australian-based biotech firm Actinogen Medical has begun patient enrolment and dosing in the Phase II XanADu clinical trial of Xanamem for the treatment of Alzheimer’s disease.
Developed in collaboration with Edinburgh University in Scotland, Xanamem is designed to block the excess production of cortisol in the brain.
The initiation of patient enrolment follows the approval from the Australian Therapeutic Goods Administration (TGA), the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
The double-blind, randomised, placebo-controlled Phase II trial will evaluate the safety, tolerability and efficacy of Xanamem over 12 weeks in patients with mild dementia.
Actinogen Medical chief executive officer Dr Bill Ketelbey said: “It is significant that the first XanADu patient worldwide has been enrolled in Australia and we can all be justifiably proud that Australia is leading the way in developing this promising new treatment for Alzheimer’s disease.
“Given the growing number of people with Alzheimer’s and the critical importance of finding effective new drugs to treat this disease, our hope is that the development of Xanamem will make a real difference to Alzheimer’s patients, and their carers and families worldwide.”
With the first patient recruited at the Central Coast Neurosciences Research site in New South Wales, Australia, the trial is expected to enrol a total of 174 patients across 20 clinical sites in the US, the UK and Australia.
The final patient is expected to be enrolled into the trial by the fourth quarter of next year and the top line results are estimated to be reported in the first quarter of 2019.