A biomarker trial of Actinogen Medical’s (ASX: ACW) lead candidate Xanamem has been published in the peer-reviewed Journal of Alzheimer’s Disease, with results showing the drug has the potential to slow disease progression in patients with elevated levels of phosphorylated tau (pTau).
The trial comprised 72 participants from Actinogen’s previous XanADu Phase 2a trial who had available stored plasma (blood) samples on file and had consented to their use.
XanADu aimed to assess the safety, tolerability and efficacy of Xanamem in patients with mild Alzheimer’s disease.
Double-blind trial
The biomarker trial was conducted as a standalone prospective double-blind trial, in which participants were treated with either 10 milligrams of Xanamem or a placebo once daily for 12 weeks.
The panel of biomarkers was analysed by researchers at the clinical neurochemistry laboratory at the University of Gothenburg in Sweden, who were “blinded” to the treatment assignment of each individual.
In the 34 patients found to have elevated levels of the pTau181 biomarker, a potentially large and clinically-meaningful Xanamem treatment effect was seen in the CDR-SB, an 18-point clinical dementia scale that rates functional and cognitive abilities.
Positive trends were also observed in a neuropsychological test battery of cognition.
‘Compelling data’
The results are reported to be consistent with international guidelines, which consider elevated plasma pTau to be a viable diagnostic option for Alzheimer’s disease and could potentially be used as an alternative or adjunct to amyloid positron emission tomography brain scans for patients with progressive disease.
Actinogen’s chief medical officer Dr Dana Hilt said Xanamem was the first drug in its class to deliver such “compelling data” from a trial.
“We already know how effective Xanamem is at reaching its target enzyme in the brain at safe and well-tolerated daily doses,” he said.
“No other 11β-HSD1 inhibitor has ever demonstrated robust central nervous system target engagement in this direct way.”
“Now, the Journal of Alzheimer’s Disease reports that Xanamem 10mg potentially slows Alzheimer’s disease progression in patients with high plasma pTau181.”
“[This] is consistent with our prior Phase 1b studies in older healthy volunteers, which showed improved attention and working memory.”