Actinogen Medical Limited (ASX: ACW) today announces positive Phase 2a clinical data from its Alzheimer's Disease (AD) biomarker study, which validates the Company's planned Xanamem program in AD.
Key points:
- Phase 2a placebo-controlled trial re-run in biomarker-positive patients using available blood biomarker levels in 72 patients from the prior XanADu study of 185 patients with mild AD over 12 weeks
- Used a pre-specified analysis plan and protocol to avoid bias
- Patients with elevated blood pTau above the median value showed a clinically significant Xanamem effect on the CDR-SB endpoint plus trends in a Neurologic Test Battery (NTB) and the Mini Mental State Exam (MMSE)
- CDR-SB effect of 0.6 - 0.8 points is larger than the 0.45 points reported recently for the anti-amyloid antibody lecanemab and represents a 60-80% reduction in progression over 12 weeks compared with placebo (lecanemab reported to show 27% over 18 months)[1]
- Twice as many patients (56%) in the Xanamem group were stable or improved compared with placebo
- CDR-SB will be a primary endpoint in the upcoming Phase 2b trial of 6 months duration
- Regulatory path to approval in AD is clear and uncontroversial using CDR-SB
- Findings significantly de-risk and improve AD program efficiency.
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