Actinogen Medical phase two Alzheimer’s clinical trial disappoints

Actinogen Medical ASX ACW Phase 2 Alzheimer's disease trial results fail dementia
Actinogen Medical’s XanADu phase two clinical trial of Xanamem failed to effectively improve cognitive function in patients with mild Alzheimer’s disease.

Biotech company Actinogen Medical (ASX: ACW) has reported a mixed bag of results including some disappointing outcomes from its XanADu phase two clinical trial treating patients with mild dementia due to Alzheimer’s disease.

According to initial data released today, the trial established that a 10mg daily dose of Xanamem is safe and can effectively inhibit cortisol production, as demonstrated by the expected rise in related hormones including adrenocorticotropic hormone.

However, the drug did not demonstrate adequate efficacy in improving cognition in mild Alzheimer’s disease, with the primary and secondary endpoint measures failing to demonstrate statistical differences between Xanamem 10mg and the placebo.

This disappointing result is a blow to the company after last month’s positive announcement that it had expanded its clinical development program to include cognitive impairment in mood disorders and schizophrenia as new potential indications for the drug.

Nevertheless, Actinogen chief executive officer Dr Bill Ketelbey has remained optimistic, describing the XanADu trial results as “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,” he said.

According to Actinogen, further analysis is underway to explore trends in the data and to identify any specific cognitive domains in which positive trends may be evident.

Higher dosage studies

The company’s development program, including the XanaHES safety studies which are evaluating Xanamem at higher dosages (20mg and 30mg), is designed to provide greater insight into the drug’s safety and its activity on cortisol production in the brain.

Initial results from these studies are expected to be announced by the end of June.

“The company is confident in the relationship between raised cortisol and cognitive impairment. The inhibition of cortisol production in the brain with Xanamem represents a compelling approach to treating cognitive impairment in Alzheimer’s and other neurological diseases, such as bipolar disorder and schizophrenia,” Actinogen stated.

The company’s share price took a dive on the news, plunging more than 70% from $0.048 to $0.014. By midday trade, Actinogen shares were down 68.75% at $0.015.