Actinogen (ASX: ACW), an Australian company focused on the development of novel treatments for Alzheimer’s disease and other major age-related neurodegenerative disorders, has announced an update on the second Phase I study for its lead drug candidate, XANAMEM.
Following the successful recruitment and dosing at 10mg of the first cohort of 8 participants, the results were reviewed by the independent Dose Escalation Committee.
According to the company, the Committee was satisfied with the safety, tolerability and pharmacokinetic results and allowed for a dose escalation to 25mg for the next cohort of 8 participants.
Actinogen Medical expects the next cohort to be dosed in late March.
XANAMEM works by blocking the production of cortisol - the stress hormone - in the hippocampus and frontal cortex, the areas of the brain most affected by Alzheimer’s disease.
"There is growing evidence that chronic stress and elevated cortisol levels lead to changes in the brain affecting memory and to the development of amyloid plaques and neural death – the hallmarks of Alzheimer’s disease," the company said.
In this second Phase I study, a total of 24 healthy volunteers will be given doses of 10mg, 25mg and 35mg of XANAMEM, in a multiple ascending dose (MAD) with eight participants in each cohort.
The primary endpoint of the study is to confirm safety and tolerability of the drug.
In addition, the study will demonstrate how the body absorbs and metabolises XANAMEM and the optimal dose for the drug.
This double-blinded, placebo controlled study is being conducted at Linear Clinical Research, a clinical trial facility that is part of the QEII Medical Centre in Perth.