- Actinogen Medical (ACW) sees new “positive” data from its phase 2A Alzheimer Disease (AD) biomarker study
- The study tested the company’s drug, Xanamem, on 72 patients across the US, UK and Australia with previously identified mild AD
- Results found a positive impact on biomarker positive AD patients, improving the clinical dementia rating with a 60 per cent reduction in progression of the disease compared with a placebo
- The company says the results pave the way to getting regulatory approval, as well as significantly de-risking and improving the programs efficiency
- ACW shares end the day 25 per cent in the green to close at 12 cents
Actinogen Medical (ACW) says new “positive” data from its recent phase 2A Alzheimer Disease (AD) biomarker study validates its Xanamem product.
Xanamem is the company’s small molecule drug which targets the stress hormone, cortisol, which has been shown to coincide with cognitive decline people are exposed to chronically high levels.
In this phase of the study, 72 patients who were previously identified as having mild Alzheimer’s Disease, were either given 10 milligrams of the drug or a placebo once daily for 12 weeks.
The study spanned the US, UK and Australia, with all 72 patients previously identified from the prior Phase 2a placebo-controlled XanADu study.
The company found patients given Xanamem had a “clinically significant” effect on their Clinical Dementia Rating – Sum of Boxes (CDR-SB), with a 60 per cent relative reduction in progression of the disease compared with the placebo.
56 per cent of patients treated with Xanamem remained stable or saw an improvement – twice as many as the placebo.
This study follows two previous trials targeting patients with pTau biomarker-positive Alzheimers Disease.
Elevated blood pTau has been shown to identify people with the Alzheimers Disease type of dementia that is likely to progress to more severe disease.
While Xanamem didn’t have an effect on the actual level of pTau biomarkers, it did show an improvement on the CDR-SB endpoint plus trends in a Neurologic Test Battery (NTB) and the Mini Mental State Exam (MMSE).
The company says these results will have a positive affect on their regulatory path to approval, and significantly de-risks and improves AD program efficiency.
“Xanamem has the potential to be a novel daily oral therapy for Alzheimers Disease and other conditions that could be safely used alone or in combination with other therapies,” CEO and Managing Director Dr Steven Gourlay said.
“The results affirm our confidence in the upcoming clinical trials that will confirm if Xanamem can make a significant improvement in the lives of patients and their families living with serious neurological and psychiatric conditions.”
ACW shares ended the day 25 per cent in the green to close at 12 cents.