- Actinogen Medical (ACW) receives approval from the USA FDA to proceed with its six-month, phase 2b, placebo-controlled clinical trial of Xanamem
- Under the planned trial, Actinogen will enrol 330 patients with mild Alzheimer’s Disease and progressive disease for treatment with Xanamem
- ACW Chair Geoff Brooke says the FDA approval is a “significant milestone” for the company and a testament to the expertise of Actinogen’s team around the world
- The trial will commence in the first half of 2023, with results expected in late 2024
- Shares in Actinogen are up 3.13 per cent and trading at 10 cents at 1:51 pm AEDT
Actinogen Medical (ACW) has received approval from the US Food and Drug Administration (FDA) to proceed with its six-month, Phase 2b, placebo-controlled clinical trial of Xanamem.
Under the trial, Actinogen will enrol 330 patients with mild Alzheimer’s Disease and progressive disease and will compare the effects of Xanamem to a placebo.
Chair Geoff Brooke said the FDA approval was a “significant milestone” for the company and said it was a testament to the expertise of Actinogen’s management team, advisors and clinical investigators around the world.
“The company, guided by CEO Steven Gourlay, has delivered two positive clinical results this year as well as the successful completion of nonclinical and manufacturing activities,” Dr Brooke said.
“We look forward to more good news in 2023 as we commence enrolment in the XanaMIA Phase 2b Alzheimer’s Disease trial and continue with the XanaCIDD Phase 2 Depression trial.”
Patients enrolled in the upcoming trial will receive treatment over six months, with five milligrams, 10 milligrams or a placebo to be administered once a day.
The trial will commence in the first half of 2023 with results expected in late 2024.
Shares in Actinogen were up 3.13 per cent and trading at 10 cents as of 1:51 pm AEDT.