FDA agrees to Actinogen six-month Phase 2b Alzheimer's Disease trial

23 December 2022 | Friday | News

Exploring Xanamem® and the "cortisol hypothesis" for more than 6 million Americans suffering from Alzheimer's Disease[1]
Image Source : Public Domain

Image Source : Public Domain

Actinogen Medical Limited (ASX: ACW) is pleased to announce receipt today of agreement from the US Food and Drug Administration (FDA) to proceed with its six-month, Phase 2b, placebo-controlled clinical trial of Xanamem in patients with early stages of Alzheimer's Disease (AD).


This agreement comes in the context of the Company recently updating its FDA Investigational New Drug (IND) dossier with new nonclinical and clinical information to support the trial protocol.

The planned Phase 2b trial will enrol 330 patients with mild AD and progressive disease, using clinical criteria and confirmed by an elevated level of pTau181 protein in the blood. Patients will be randomized to treatment over six months with 5 mg, 10 mg or placebo once a day.

Key efficacy endpoints will be those that have shown Xanamem effect in prior trials: the Clinical Dementia Rating scale – Sum of Boxes (CDR-SB) and the Cogstate computerized test battery of attention and working memory.

The trial will commence in the first half of 2023 with results expected in late 2024.

Actinogen Chair, Dr Geoff Brooke, said:

"The FDA approval of our upcoming Phase 2b Alzheimer's Disease trial is a significant milestone for the Company. This is a testament to the expertise of our 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. 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."


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