Aviceda Therapeutics has initiated the second part of its Phase II/III SIGLEC trial for AVD-104, an ophthalmic candidate aimed at treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The company has dosed the first subject in this phase, marking a pivotal moment in advancing potential disease-modifying treatments.
The double-masked, multicenter, randomized, controlled trial will span 12 months, with an optional extension of an additional 12 months. AVD-104 will be compared with an active comparator, avacincaptad pegol, building upon the efficacy and safety observed in Part 1.
Dr. David Callanan, Aviceda’s Chief Medical Officer, highlighted positive safety profiles observed in Part 1, with patients showing improvements in Best Corrected Visual Acuity (BCVA) at 3 months. This paved the way for the swift initiation of Part 2, focused on exploring AVD-104 outcomes on GA, with a unique opportunity for a side-by-side comparison with an active comparator.
Mohamed Genead, MD, CEO of Aviceda, emphasized AVD-104's dual-mechanism approach, targeting both macrophage/microglial-mediated inflammation and the complement pathway.
If proven safe and effective, this approach could bring about a paradigm shift in treating GA, moving beyond addressing complement dysregulation.
The trial's primary endpoint is the variation in the growth rate of the GA area at 12 months, measured by fundus autofluorescence. Subjects will receive either a low or high dose of AVD-104 or the active comparator.
Part 2 of the SIGLEC trial is a multi-center, double-masked, randomized, controlled trial, assessing safety and efficacy outcomes over 12 months, with an optional 12-month extension.
Patients assigned to AVD-104 treatment will receive either low-dose AVD-104, high-dose AVD-104, or the active comparator. The trial will explore visual functional and anatomic efficacy measures, comparing AVD-104 with the active comparator.
Part 1 was a safety and dose-escalation trial with 30 patients receiving a single intravitreal injection of AVD-104, followed for 3 months. All patients tolerated the single dose well, with no drug-related severe adverse reactions observed.
AVD-104 has demonstrated robust in-vitro/vivo efficacy, inhibiting inflammatory and complement pathways. The potential for dosing every 4-6 months adds to the appeal, coupled with anti-neovascular activity equivalent to aflibercept in ocular CNV models.
Earlier in the year, Aviceda presented positive topline data from Part 1 of the Phase 2/3 SIGLEC trial, indicating positive safety and efficacy outcomes observed at 3 months post a single dose of AVD-104.
Dr. Callanan expressed the company's eagerness to move forward into Part 2 of SIGLEC, hoping to demonstrate the meaningful improvement AVD-104 can provide over therapies solely based on complement inhibition. The progression of AVD-104 through clinical trials holds promise for transforming the landscape of AMD treatment, addressing geographic atrophy with a comprehensive approach.