Aviceda Therapeutics has announced the completion of enrollment for its Phase 2b SIGLEC study, which is evaluating the safety and efficacy of AVD-104 for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This randomized, double-masked, multicenter trial compares AVD-104 to avacincaptad pegol (IZERVAY) and aims to address unmet needs in the current GA treatment landscape.
AVD-104: A Novel Approach to GA Treatment
AVD-104 is an optimized intravitreal glycomimetic nanoparticle designed to inhibit macrophage and complement cascade amplification, offering a dual mechanism of action for treating GA. The Phase 2b study includes approximately 300 patients randomized to receive either high-dose AVD-104 every other month, low-dose AVD-104 monthly, or avacincaptad pegol monthly.
Study Design and Endpoints
The SIGLEC study is a two-part US clinical trial consisting of a Phase 2a and a Phase 2b study. Part 2 of the Phase 2b study is a multicenter, double-masked, randomized trial designed to evaluate the treatment effect of AVD-104 in patients with GA secondary to AMD. The primary endpoint is the difference in the growth rate of the GA area at 12 months in patients treated with AVD-104 versus those receiving avacincaptad pegol, measured by fundus autofluorescence.
Patients enrolled in the study had a best-corrected visual acuity (BCVA) of 20/320 or higher and GA lesions ranging from 2.5 mm² to 17.5 mm² in size. Patients with exudative AMD, choroidal neovascularization, or other ocular conditions were excluded.
Promising Phase 2a Results
Data from the Phase 2a trial showed that AVD-104 was well-tolerated, with no drug-related ocular or systemic serious adverse reactions observed at 3 months after a single intravitreal injection. Furthermore, compared to untreated fellow eyes with GA, AVD-104 demonstrated a greater reduction in GA lesion progression, improved hyperautofluorescence imaging outcomes, and stabilization or gain of BCVA.
Addressing Unmet Needs in GA Treatment
"The current GA landscape contains a number of unmet needs," said David Callanan, MD, Aviceda’s Chief Medical Officer. "Based on our differentiated dual mechanisms of action and strong phase 2a results, we believe AVD-104 has the potential to meaningfully alter the course of GA progression by enabling tangible functional benefits and neuroprotection of retinal tissue."
Anticipated Data Release
The 12-month data from the Phase 2b SIGLEC study is expected to be released in the second half of 2025. Following the initial 12-month treatment period, participants have the option to remain in the study for an additional year.
