Anavex Reports 36% ADAS-Cog13 Gain, Nearly 50% in Subgroup, No ARIA
Anavex CEO Christopher Missling reported a 36% improvement on ADAS-Cog13 for oral Alzheimer’s drug blarcamesine, rising to nearly 50% in a pre-specified subgroup, with no ARIA events or deaths during a 192-week extension. He cited slowed brain atrophy, Aβ42 biomarker gains and robust cash runway ahead of regulatory milestones.
1. Pipeline Efficacy Data
CEO Christopher Missling presented Phase IIb/III results for blarcamesine, reporting a 36% improvement on the primary ADAS-Cog13 cognitive scale at 48 weeks and nearly 50% improvement in a pre-specified subgroup of sigma-1 wild type patients.
2. Safety Profile
The trial showed a reliable safety profile with no ARIA events or neuroimaging-related neurological adverse effects, no drug-related deaths through a 192-week open-label extension, and dizziness identified as the most common adverse event.
3. Biomarker and Imaging Findings
Missling highlighted significant slowing of brain atrophy across multiple regions and a meaningful change in the plasma Aβ42 ratio, corroborating the clinical efficacy signals observed on cognitive endpoints.
4. Cash Runway and Next Steps
Anavex emphasized a solid cash position and intellectual property runway sufficient to support upcoming regulatory submissions and clinical milestones for its personalized oral CNS therapy platform.