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.
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.”
Part 2 of the SIGLEC trial is a multi-center, double-masked, randomized, controlled trial that will assess safety and efficacy outcomes of AVD-104 and an active comparator (avacincaptad pegol) for the treatment of GA secondary to AMD. Patients will be dosed for 12 months, with the opportunity to remain in the study for an additional 12 months. Those assigned to treatment with AVD-104 will receive either low-dose AVD-104, high-dose AVD-104, or the active comparator. The primary endpoint will be the difference in growth rate of the GA area in patients treated with AVD-104 versus those receiving active comparator at 12 months as measured by fundus autofluorescence. Numerous other visual functional and anatomic efficacy measures will also be explored and compared between AVD-104 and the active comparator. Further information regarding the Phase 2/3 SIGLEC trial can be found HERE.
Part 1 of the SIGLEC trial was a multi-center, open-label safety and dose-escalation trial of 30 patients who received a single intravitreal injection of AVD-104 and were followed for 3 months. In Part 1, all patients tolerated a single dose of AVD-104 at month 3, and no drug-related ocular or systemic severe adverse reactions were observed. Read more about the topline data from Part 1 of SIGLEC HERE.
About Aviceda Therapeutics and AVD-104
Aviceda is 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. Our lead clinical-stage ophthalmic candidate, AVD-104, was developed from our proprietary HALOS™ nanotechnology platform, is under investigation for the treatment of GA secondary to age-related macular degeneration (AMD) and diabetic macular edema. AVD-104 is a promising intravitreal glycan-coated nanoparticle with a dual mechanism of action that modulates critical inflammatory cellular and complement pathways through 1) direct inhibition of damaging phagocytic/inflammatory macrophages, resolution of neovascular VEGF-producing macrophages, and repolarization of activated microglia to their neuroprotective resolution state, and 2) inhibition of complement cascade amplification.
Aviceda Therapeutics Inc.