Aviceda Therapeutics Announces First Patient Dosed in Part 2 of the Phase 2/3 SIGLEC Clinical Trial Assessing AVD-104 for the Treatment of Geographic Atrophy
Part 2 of the Phase 2/3 SIGLEC clinical trial is designed and powered to serve as the first pivotal trial to support approval of AVD-104 in geographic atrophy.
Part 2 of SIGLEC is expected to enroll approximately 300 patients who will be randomly assigned to two arms of AVD-104 or active comparator (avacincaptad pegol) and will be assessed at 12 months.
Excerpt from the Press Release:
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aviceda Therapeutics, a clinical-stage biotech company focused on developing novel glyco-immune therapeutics by harnessing the body’s natural immune system to modulate inflammation by using highly selective ligands designed to have maximum specificity towards target immune cells and diseases, announced today that it has dosed the first patient in Part 2 of the Phase 2/3 SIGLEC trial for AVD-104 in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
“Based on the efficacy and safety we saw in Part 1, we moved rapidly to initiate the Part 2 by activating sites and enrollment for this potentially disease-modifying treatment,” said David Callanan, M.D., Aviceda’s Chief Medical Officer and Senior Vice President. “In Part 1 of SIGLEC, we found that AVD-104 had a positive safety profile, and that patients with GA dosed with AVD-104 showed BCVA improvements at 3 months (Found HERE). We will now further explore outcomes of AVD-104 on GA, this time with the opportunity to compare them to those of a comparator arm.”
“Current treatment options for GA address only complement dysregulation,” explained Aviceda Co-founder and CEO Mohamed Genead, M.D. “AVD-104 addresses both macrophage/ microglial-mediated inflammation while also targeting the complement pathway. If this dual-mechanism approach continues to prove to be safe and effective, we may soon see a paradigm shift in how we treat GA.”
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