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Annexon Outlines Global Registrational Program for ANX007 in Geographic Atrophy with FDA Alignment on Vision Preservation as Primary Endpoint
Alignment with FDA on Best Corrected Visual Acuity ≥ 15-Letter Loss as Primary Outcome Measure - Representing the Highest Value Outcome to Patients and
About this update from Annexon, Inc.
[{"type":"text","content":"Alignment with FDA on Best Corrected Visual Acuity ≥ 15-Letter Loss as Primary Outcome Measure - Representing the Highest Value Outcome to Patients and Physicians ARCHER II, a Global Sham-Controlled Trial Supporting a Potentially Faster Path to Registration, Expected to Initiate in Mid-2024 ARROW, a Head-to-Head Trial using SYFOVRE® as an Injection Comparator to Differentiate Vision Protection from Slowing of Lesion Growth, Expected to Initiate in Late 2024 BRISBANE, Calif., Dec. 20, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement-based medicines for people living with devastating inflammation-related diseases, today outlined its global registrational program for ANX007, a first-in-class C1q and classical complement inhibitor, for the treatment of patients with geographic atrophy (GA). Annexon has gained alignment with the U.S. Food and Drug Administration (FDA) on a Phase 3 registration program that includes using, for the first-time, the prevention of ≥15-letter loss of best corrected visual acuity (BCVA) as the primary outcome measure, as well as conducting a comparison of ANX007 to an injection agent, consistent with requests for trials across ophthalmic indications. Notably, the FDA has not required Annexon to study the slowing of lesion growth as measured by fundus autofluorescence (FAF), an anatomical endpoint used for the approval of other GA programs. “We are thrilled to have aligned with FDA on vision preservation as the primary endpoint in our Phase 3 GA program, based on the statistically significant and dose-dependent visual protection ANX007 demonstrated in the Phase 2 ARCHER trial,” said Douglas Love, chief executive officer of Annexon. “Blocking C1q with ANX007 is designed to stop classical complement inflammation that drives photoreceptor damage and vision loss. Considering the robust preservation of vision demonstrated by ANX007 in the ARCHER trial, and that current FDA-approved treatments have not shown a meaningful functional benefit after years of treatment, we are encouraged by the potential for ANX007 to demonstrate significant protection against vision loss as measured by BCVA ≥15-letter loss in a head-to-head study. We are excited to embark on this global pivotal program with the aim of providing meaningful functional ...