Actinogen Medical (ASX:ACW) reports positive 2a clinical data

Nick Sundich Nick Sundich, October 10, 2022

Actinogen Medical (ASX: ACW) rose again today and this time it was due to positive clinical data. When share prices of ASX biotechs that fight dementia rise from clinical trial success or clinical approval, it has typically been triggered by news from their larger peers in North America rather than their own success. But today, ACW did it all on its own!

 

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Actinogen Medical’s Phase 2a data looks good

Actinogen Medical reported data from a Phase 2a clinical trial of 72 patients on the company’s Xanamem drug, administered as an oral drug. These patients had a clinical diagnosis of mild Alzheimer’s Disease and were treated with Xanamem 10mg or placebo once daily for 12 weeks.

In a nutshell, there was a 60% reduction in Alzheimer’s disease progression compared with placebo treatment. The average patient to have taken Xanamem saw an average effect size of 0.6-0.8 points on the CDR-SB scale (Clinical Dementia Rating scale Sum of Boxes) compared to 0.45 points compared to placebo. 

Futhermore, the company also reported twice as many patients taking Xanamem had stable or improved disease compared with placebo. The majority of its patients were protected from disease progression. 

 

 

Actiongen Medical (ASX:ACW) share price chart (Graph: TradingView)

 

So now what?

Actinogen Medical will conduct a Phase 2b trial against Alzheimer’s Disease along with a Phase 2a trial in Cognitive Impairment in Depressive Disorder (CIDD). 

The company claims its pathway to eventual regulatory approval is now de-risked, not just because of the results, but because the FDA now approves CDR-SB as an acceptable endpoint to assess dementia in early-stage Alzheimer’s. 

However, eventual regulatory approval is at least a couple of years off, having not even been listed in the company’s catalyst timeline up to 2024. Still, Actinogen Medical will be busy, enrolling people into its future studies, which will report within a couple of years. 

 

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