Actinogen gets go-ahead for Xanamem study dose increase
THE ROADHOUSE PHARMACY: Actinogen Limited (ASX: ACW) has had the results of a Phase I study for the company’s lead drug candidate, Xanamem™ reviewed by the independent Dose Escalation Committee.
Actinogen is an Australian biotechnology company focused on the development of novel treatments for Alzheimer’s disease and other major age-related neurodegenerative disorders.
The company has completed recruitment and dosing at 10mg of the first cohort of eight participants.
On completion of its review the independent Dose Escalation Committee declared it was satisfied with the safety, tolerability and pharmacokinetic results.
Actinogen said the Committee has allowed for a dose escalation to 25mg for a subsequent cohort of a further eight participants, which the company expects to be carried out in late March.
“Xanamem’s novel mechanism of action sets it apart from existing Alzheimer’s treatments,” Actinogen Limited said in its ASX announcement.
“It 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.”
Actinogen outlined the specifics of the upcoming second Phase I study, in which 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,” Actinogen said.
“In addition the study will demonstrate how the body absorbs and metabolises
Xanamem and the optimal dose for the drug.”
The double-blinded, placebo controlled study is being conducted at Linear Clinical Research, part of the QEII Medical Centre in Perth, Western Australia.
Website: www.actinogen.com.au