CAMBRIDGE, Mass. — Aviceda Therapeutics, a clinical-stage biotechnology company developing therapies for retinal diseases, on Monday reported topline results from its SIGLEC Phase 2b study evaluating AVD-104 in patients with geographic atrophy secondary to age-related macular degeneration.
The company said the primary endpoint analysis showed no statistical difference in the rate of change in geographic atrophy area between AVD-104 and monthly avacincaptad pegol. Aviceda noted that imbalances in key baseline lesion characteristics across treatment arms contributed to lesion-growth outcomes. Despite this, treatment with AVD-104 demonstrated clinically meaningful reductions in lesion growth compared with historical natural history data, sustained visual acuity gains, and a favorable safety profile, including a low rate of conversion to neovascular age-related macular degeneration.
According to Aviceda, both AVD-104 dosing arms showed approximately 31 to 38 percent less lesion growth than reported in prior randomized, placebo-controlled trials or previously published natural history cohorts. In the monthly AVD-104 treatment arm, participants experienced an improvement in mean best-corrected visual acuity of 0.6 letters over the full 12-month study period, an outcome the company said has not been observed in other geographic atrophy clinical trials to date.
The company also reported that 28.9 percent of participants in the monthly treatment arm achieved visual acuity gains of at least five letters, 16.9 percent achieved gains of at least 10 letters, and 4.8 percent achieved gains of at least 15 letters. Conversion to neovascular age-related macular degeneration occurred in 2 percent of participants in the monthly dosing arm.
Aviceda said no drug-related serious adverse events were observed in participants treated with AVD-104. The most common treatment-emergent adverse event reported was floaters.
“The SIGLEC study represents the first clinical validation of glycoimmune checkpoint therapy to modulate macrophages and microglia to treat geographic atrophy,” said Jeffrey Nau, PhD, MMS, Chief Executive Officer of Aviceda Therapeutics. “These results reinforce our belief that AVD-104 can provide meaningful functional vision benefit while reducing lesion progression, and has the potential to become a differentiated therapy addressing a significant unmet medical need for patients living with GA.”
David Callanan, MD, Chief Medical Officer of Aviceda Therapeutics, said the company was encouraged by the visual acuity improvements and safety profile observed in the study. “We are encouraged by the magnitude of visual acuity gains, including protection from significant vision loss, reduction in lesion growth relative to historical sham and expected natural history, and the compelling safety profile observed with monthly AVD-104, in this first-ever multi-dose trial of AVD-104,” he said. “AVD-104 demonstrated a favorable safety and tolerability profile, with a low rate of neovascular AMD conversion and no serious drug-related adverse events, including no retinal vasculitis. We believe AVD-104 is poised to address critical gaps in current GA therapies that limit adoption, such as the lack of functional vision benefit and the safety limitations of neovascular AMD conversion.”
