Actinogen Limited (Actinogen Medical, ASX: ACW), an Australian biotechnology company focused on the development of novel treatments for Alzheimer’s disease and other major age-related neurodegenerative disorders, is pleased to announce that it has received ethics approval to initiate the third and final stage of the second Phase I trial of its lead Alzheimer’s drug candidate, Xanamem™.
This final stage will examine the CNS pharmacokinetics of Xanamem™ and will involve the recruitment of four healthy volunteers. The primary endpoint is to demonstrate that Xanamem™ is efficiently delivered to the brain, its primary site of action in Alzheimer’s disease. The trial is being conducted at Linear Clinical Research, a world-class clinical trial facility that is part of the QEII Medical Centre in Perth, Western Australia.
In addition, the second stage of the Phase I trial, a fed-fasted dosing of 12 participants on 35mg of Xanamem™, has successfully completed with results expected in August 2015. Both the first and second stages of this study demonstrated the safety and tolerability of Xanamem™, even at the highest dose of 35mg twice daily.
Actinogen is also pleased to announce that dosing in the final pre-clinical toxicology study is well underway with the results expected before the end of the year.
Significantly, all these studies remain on-track, with results to be incorporated into the research documentation supporting the all-important Phase II study of Xanamem™ in Alzheimer’s patients. The results will enable an Investigational New Drug (IND) application to the FDA later this year for the Phase II trial to be run in the US. The trial will also be run in Australia, New Zealand and the UK, and is expected to commence in the first half of 2016
“The ongoing excellent progress of this Xanamem™ study sets us up well to start the Phase II trial of Xanamem™ in patients with Alzheimer’s disease in the first half of 2016. It is particularly pleasing to continue on-track with our development plans for this promising new treatment for Alzheimer’s disease,” said Actinogen Medical CEO, Dr Bill Ketelbey.