The US Food and Drug Administration (FDA) has approved Actinogen Medical’s
(ASX:ACW) Investigational New Drug application to start a Phase II clinical trial of its drug, Xanamem.
Xanamem is used to treat mild Alzhemier’s disease. And the new trial, called XanADu, will enrol 174 patients across the US, UK and Australia.
The company says Xanamem is different from other Alzheimer’s treatments as it has been specifically designed to block excess production of cortisol, the stress hormone, in the areas of the brain most affected by Alzheimer’s disease.
The company expects to receive similar approvals from Australian and British authorities in the next two months, and the trial to actively begin recruiting patients by the second quarter of this year.
Actinogen Medical posted a net loss of $3.6 million at 30 June 2016.
