Anavex Life Sciences Announces Positive up to 4-Years Oral Blarcamesine Results from Phase IIb/III Open-Label Extension Trial in Early Alzheimer's Disease

Core Insights - The ATTENTION-AD trial data presented at the AD/PDTM 2025 Conference indicates that oral blarcamesine has a disease-modifying effect and emphasizes the importance of early and continuous long-term treatment for chronic Alzheimer's disease [1][3][10] Efficacy Data - Continuous treatment with blarcamesine for up to four years showed a favorable safety profile with no treatment-related deaths and no serious neuroimaging adverse events [2][11] - The delayed-start analysis demonstrated a significant difference in cognitive function between early and late treatment groups, with an LS mean difference of -3.83 for ADAS-Cog13 (P = 0.0165) and +4.30 for ADCS-ADL (P = 0.0206) at Week 192 [6][7] - Patients who started treatment earlier exhibited greater stability in cognitive function compared to those who delayed treatment by approximately one year [6][10] - The analysis confirmed that continuous treatment without interruption led to improved outcomes in both cognition and function, with LS mean differences of -4.20 (P = 0.0083) for ADAS-Cog13 and +5.75 (P = 0.0015) for ADCS-ADL at Week 192 [9][10] Safety Data - Blarcamesine was associated with mostly mild to moderate adverse events, primarily during the initial titration phase, and no severe or life-threatening adverse events were reported [11][12] - The frequency of dizziness, the most common treatment-emergent adverse event, decreased significantly from 25.2% in the previous trial to 9.6% in the ATTENTION-AD trial, indicating better management of side effects [12] Compassionate Use - Currently, 74 participants are receiving blarcamesine through a Compassionate Use Program, with some individuals having been on the treatment for over nine years without severe adverse events [14] Industry Implications - The results suggest a potential shift towards more effective and patient-friendly Alzheimer's treatments, addressing disparities in care within global healthcare systems [4][15] - The findings support the notion that early diagnosis and treatment can lead to greater clinical benefits for patients with Alzheimer's disease [4][15]