Enrollment complete of phase 2b of SIGLEC study to assess safety and efficacy of AVD-104 for GA secondary to AMD

(Image credit: AdobeStock/Parradee)

Aviceda Therapeutics has completed enrollment of the phase 2b trial of the SIGLEC Study. The study will assess the safety and efficacy of AVD-104, the company’s formulation designed to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

AVD-104 is described by the company as an optimized intravitreal glycomimetic nanoparticle designed to increase the efficacy and safety of GA treatment via its differentiated dual mechanism of action that works farther upstream to inhibit macrophage and complement cascade amplification.

The phase 2b study will compare the safety and efficacy of high- and low-dose AVD-104 and avacincaptad pegol (IZERVAY, Iveric Bio). Thus far, about 100 patients have been enrolled in each study arm.

“The current GA landscape contains a number of unmet needs,” commented David Callanan, MD, Aviceda’s Chief Medical Officer in the press release. “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 trial

The SIGLEC Study is a two-part US clinical trial comprised of a phase 2a and a phase 2b study.

The phase 2a results showed no drug-related ocular or systemic serious adverse reactions at 3 months after 1 intravitreal injection of AVD-104 and concluded that the drug was well tolerated. Compared with untreated fellow eyes with GA at 3 months and the natural history, the results also showed that AVD-104 resulted in a 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), the company reported.

Part 1 of the phase 2b study will be a multicenter, open-label safety and dose-escalation study with a potential enrollment of 30 participants with GA secondary to AMD. The participants will be treated with 1 intravitreal injection of AVD-104 and followed for 3 months for the observation. Aqueous humor and peripheral blood will be drawn for pharmacokinetic and pharmacodynamic evaluations.

Part 2 of the phase 2b study will be a multicenter, double-masked, randomized trial to evaluate the treatment effect of AVD-104 on participants with GA secondary to AMD. In this segment, the patients will be randomized to receive either high-dose AVD-104 every other month, low-dose AVD-104 monthly, or avacincaptad pegol monthly. The primary endpoint will be the difference in the growth rate of the GA area at 12 months in patients treated with AVD-104 versus those receiving avacincaptad pegol.

The patients were enrolled who had a BCVA of 20/320 or higher and GA lesions ranging from 2.5 mm² to 17.5 mm² in size. Patients were excluded who had exudative AMD, choroidal neovascularization, or any other ocular condition other than GA.

The 12-month data from the phase 2b SIGLEC study is expected to be released in the second half of 2025.

Reference:

1. Aviceda Therapeutics Completes Enrollment of Phase 2b SIGLEC Study Assessing the Safety and Efficacy of AVD-104 for Geographic Atrophy Secondary to AMD. Aviceda Therapeutics. September 24, 2024. Accessed September 24, 2024. https://www.businesswire.com/news/home/20240923774763/en/Aviceda-Therapeutics-Completes-Enrollment-of-Phase-2b-SIGLEC-Study-Assessing-the-Safety-and-Efficacy-of-AVD-104-for-Geographic-Atrophy-Secondary-to-AMD