Actinogen Medical (ASX:ACW) has announced the peer-reviewed publication of its phase 2a biomarker trial entitled 'Plasma pTau181 Predicts Clinical Progression In A Phase 2 Randomized Controlled Trial of the 11β-HSD1 Inhibitor Xanamem for Mild Alzheimer’s Disease' in the 100th edition of the Journal of Alzheimer’s Disease.
The publication is based on data from participants comprising 72 patients from the previous XanADu phase 2a trial of mild Alzheimer’s disease (AD) who had available stored plasma samples and gave informed consent for the new trial
The company said the publication highlights include patients with elevated pTau181 had much more rapid progression than patients with lower levels in four critical clinical endpoints. In the 34 patients with elevated pTau181, a potentially significant and clinically meaningful Xanamem treatment effect compared to placebo was seen in the CDR-SB, and positive trends were observed in a Neuropsychological Test Battery of cognition.
Dr Dana Hilt, the company's chief medical officer, said, "To our knowledge, Xanamem is the first drug of this class to have such compelling data. The previously published PET study highlighted just how effective Xanamem is at reaching its target enzyme in the brain at safe and well tolerated doses of 5 and 10 mg/day. No other inhibitor of 11β-HSD1 has ever demonstrated robust central nervous system (CNS) target engagement in this direct way.
“This new peer-reviewed publication reports that Xanamem 10 mg potentially slows AD progression in patients with high plasma pTau181. The other trends toward benefit on cognition are consistent with our two, prior phase 1b studies in older healthy volunteers which showed improved attention and working memory.
“Further data on cognition are anticipated when the XanaCIDD trial of cognitive impairment and major depressive disorder reports results next quarter. The XanaMIA phase 2b trial in 220 patients with mild to moderate AD is ongoing.”