Aviceda Completes Enrollment for Phase 2b SIGLEC Study for Geographic Atrophy Treatment
Aviceda Therapeutics announced the completion of patient enrollment for its phase 2b SIGLEC study. The trial is comparing the safety and efficacy of the company's lead candidate, AVD-104, with avacincaptad pegol (marketed as Izervay) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
“We would like to thank our investigators and clinical development team for their extraordinary study execution achieving full enrollment in record time,” Mohamed Genead, MD, Co-founder and CEO of Aviceda, said in a company news release. “We see the rapid enrollment as a reflection of the enthusiasm surrounding AVD-104 and its potential to significantly improve outcomes for patients with geographic atrophy.”
The SIGLEC study is divided into two parts: phase 2a and phase 2b, both conducted in the US. The earlier phase 2a trial found that AVD-104 was well tolerated at 3 months following a single intravitreal injection. No drug-related ocular or systemic serious adverse reactions were reported. Compared to untreated eyes, AVD-104 treatment demonstrated a greater reduction in GA lesion progression, improved imaging outcomes, and stabilization or gain in best-corrected visual acuity (BCVA).
Phase 2b, a larger, multicenter, double-masked, randomized, controlled trial, involves 300 patients with GA secondary to AMD. Participants will receive either high-dose AVD-104 every other month, low-dose AVD-104 monthly, or avacincaptad pegol monthly. The trial’s primary endpoint is the difference in GA lesion growth rate at 12 months, measured through fundus autofluorescence.
Patients have been enrolled with GA lesions ranging from 2.5 mm² to 17.5 mm² in size. Those with exudative AMD, choroidal neovascularization, or other ocular conditions were excluded. After the initial 12-month treatment period, participants have the option to remain in the study for an additional year.
“The current GA landscape contains a number of unmet needs. 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," said David Callanan, MD, Aviceda’s Chief Medical Officer.