Annexon reports positive outcomes in Phase 3 trials for ANX005, ANX007, and ANX1502.

From GlobeNewswire: 2024-08-12 08:00:00

Annexon, Inc. reports that a single ANX005 infusion accelerated recovery in GBS patients vs. placebo in a Phase 3 trial, potentially becoming the first targeted therapy for GBS. Initial real-world evidence data expected by year-end 2024. ANX007 dosing initiated in ARCHER II trial showing significant vision protection in GA regions crucial for vision acuity.

ANX1502, an oral C1s inhibitor, successfully completed a bridging study to a twice-daily tablet. Proof-of-concept data in autoimmune disease expected Q4 2024. Annexon reported a robust balance sheet with approximately $368.7 million in cash as of June 30, 2024, providing funding into the second half of 2026.

Flagship program ANX005 in GBS showed clinically relevant effects on primary endpoints. Topline Phase 3 data expected by year-end 2024 to support BLA submission in 2025. ANX007 in GA is the only program to preserve vision while protecting vital retinal structures. ANX1502 completed a bridging study and is pursuing proof-of-concept data in CAD.

Anticipated milestones include Phase 3 topline data on ANX007 in GA expected in the second half of 2026. Initial data on ANX1502 in CAD tablet formulation anticipated in Q4 2024. Cash, cash equivalents, and short-term investments of $368.7 million provide funding into the second half of 2026, totaling expenses for R&D and G&A activities.



Read more at GlobeNewswire:: Annexon Reports Second Quarter 2024 Portfolio and Financial