Blarcamesine (ANAVEX®2-73) – Phase IIb/III Long-Term Alzheimer’s Data

🗓 Date: July 28, 2024 (Data presented) / Continued analysis up to 2025

📌 Source: Anavex Life Sciences – Phase IIb/III results presented at Alzheimer’s Association International Conference 2024, supplemented by Open-Label Extension (OLE) data

🧠 Trial Overview:

• Drug: Blarcamesine (ANAVEX®2‑73), an oral sigma‑1 receptor agonist

• Design: Phase IIb/III randomized, placebo-controlled trial in early Alzheimer’s patients across Europe, Australia, and North America

• Duration: 48 weeks with open-label extension follow-up up to 192 weeks (~3.7 years)

📈 Major Findings:

• Cognitive Decline Reduction: At 48 weeks, treatment groups experienced a 34.6–38.5% slower decline in ADAS‑Cog13 scores versus placebo

• Delayed-Start Benefit: Early-start patients retained cognitive stability longer; Week 192 difference with delayed-start group was clinically significant (mean −3.83 points, P = 0.0165)

• Brain Volume Preservation: Slowing of brain atrophy: total grey matter ~63.5%, whole brain ~37.6%, lateral ventricles ~25%

🩺 Safety Profile:

• Well-tolerated overall, mostly mild-to-moderate adverse events during dose titration

• No deaths or severe events attributed to Blarcamesine in long-term data

📢 Clinical Significance:

• One of the first oral agents showing meaningful, long-term cognitive protection in early Alzheimer’s

• Mechanism (sigma‑1 receptor modulation) differs from amyloid-targeting monoclonal antibodies, potentially safer with fewer hemorrhagic risks

• Early initiation is key: “the earlier, the better” for slowing progression and preserving function

🚀 What’s Next:

• Phase III registration trial is ongoing

• Potential FDA/EMA submission expected in late 2025

• If approved, could offer a low-cost, accessible Alzheimer’s therapy, significant for resource-limited settings

⚠️ Disclaimer: Blarcamesine is still under investigation and not yet approved by FDA or EMA. This information is for educational purposes only. Consult a healthcare professional for any treatment decisions.