XanADu trial disappoints for Actinogen Medical

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Actinogen Medical (ASX:ACW) has announced data from its phase 2 clinical trial XanADu investigating Xanamem in patients with mild dementia due to Alzheimer’s disease.

XanADu established that Xanamem is safe and has the ability to effectively inhibit cortisol production, as demonstrated by the expected increase in related hormones, including ACTH (adrenocorticotropic hormone).

However, the company said it did not demonstrate adequate efficacy in improving cognition in mild Alzheimer’s disease.

"The primary and secondary endpoint measures did not demonstrate statistical differences between Xanamem 10mg and placebo," it said.

"Further analysis is underway to explore trends in the data and to identify any specific cognitive domains in which positive trends may be evident."

The company said higher doses and longer treatment duration may be necessary to effectively demonstrate any potential to improve cognition in Alzheimer’s disease.

"The Company is confident in the relationship between raised cortisol and cognitive impairment," it said.

“These XanADu results are certainly encouraging. While 10mg Xanamem was not shown to be a clinically effective dose in Alzheimer’s disease, the safety and pharmacodynamic effects observed show potential that higher doses and a longer treatment duration of Xanamem may be efficacious,” said CEO Dr Bill Ketelbey.

“Alzheimer’s disease is a major health crisis with limited treatment options, and these results will help with the ongoing fight to find new effective therapies. The Company is extremely grateful to the patients and their carers who participated in XanADu, and to the 25 research sites and their personnel in Australia, the UK, and USA that made this study possible. Their involvement has helped generate important clinical data on the treatment of Alzheimer’s disease with Xanamem and for the ongoing development of this drug.”

The company said it will provide updates to investors following the completion of further analysis of the XanADu data and the initial results from the ongoing Xanamem studies.