The Phase 2b SIGLEC study comparing the safety and efficacy of three GA treatments—high-dose AVD-104, low-dose AVD-104, and avacincaptad pegol—has enrolled approximately 100 patients in each study arm.

12-month data from the Phase 2b SIGLEC study expected in 2H 2025.

Aviceda Therapeutics Completes Enrollment of Phase 2b SIGLEC Study Assessing the Safety and Efficacy of AVD-104 for Geographic Atrophy Secondary to AMD

Organization:
Aviceda Therapeutics Inc.
avicedapr@avicedarx.com

Aviceda Therapeutics, a private, clinical-stage biotech company focused on developing next-generation immunomodulators with a proprietary HALOS™ nanotechnology platform to alleviate chronic, non-resolving inflammation, announced today that the company completed enrollment of the Phase 2b SIGLEC study that compares the safety and efficacy of AVD-104 versus avacincaptad pegol (Izervay) in patients with 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 the Phase 2b SIGLEC study in record time,” Mohamed Genead, MD, Aviceda’s Co-founder and CEO said. “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 current GA landscape contains a number of unmet needs,” commented 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.”

SIGLEC is a two-part clinical trial comprised of a Phase 2a and a Phase 2b study. Both studies are being conducted in the United States and are designed to evaluate the safety and efficacy of intravitreally administered AVD-104 in patients with GA secondary to AMD. In Phase 2a, researchers observed no drug-related ocular or systemic serious adverse reactions at 3 months following a single intravitreal injection of AVD-104 and concluded that the drug was well tolerated. Compared with untreated fellow eyes with GA at 3 months, as well as natural history, researchers also found that AVD-104 treatment led to greater reduction in GA lesion progression, improved hyperautofluorescence imaging outcomes in the junctional zone at the border of growing GA lesions, and stabilization or gain of best-corrected visual acuity (BCVA).

SIGLEC Phase 2b is a multi-center, double-masked, randomized, controlled trial assessing the safety and efficacy of AVD-104 versus avacincaptad pegol (ACP) for the treatment of GA secondary to AMD. Approximately 300 participants with GA secondary to AMD, BCVA ?20/320, and GA lesions ranging from 2.5 mm² to 17.5 mm² in size have been enrolled. Patients with exudative AMD, choroidal neovascularization, or any other ocular condition other than GA were excluded.

Patients will be dosed for 12 months, with an opportunity to remain in the study for an additional 12 months. Participants will receive either high-dose AVD-104 every other month, low-dose AVD-104 monthly, or ACP monthly. The primary endpoint is the difference in growth rate of the GA area at 12 months in patients treated with AVD-104 versus those receiving ACP as measured by fundus autofluorescence.

Further information regarding Phase 2b of SIGLEC can be found HERE.

About Aviceda Therapeutics and AVD-104

Aviceda is a private, clinical stage biotechnology company located in Cambridge, MA, with a proprietary HALOS™ nanotechnology platform and a clinical stage ophthalmic candidate, AVD-104, for the treatment of geographic atrophy secondary to age-related macular degeneration (AMD). 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 deactivation of inflammatory microglia/macrophages’ phagocytic activity and repolarization of these activated microglia/macrophages to their healing state and 2) inhibition of complement cascade amplification.

Along with AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and multiple other therapeutic areas, including immunology, fibrosis, oncology, and neurology.

Learn more about Aviceda Therapeutics.

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