Aviceda Therapeutics has announced the completion of enrollment in its Phase 2b SIGLEC study, a clinical trial assessing the safety and efficacy of AVD-104 for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study compares two different doses of AVD-104 (high and low) against avacincaptad pegol, an approved therapy for GA.
The Phase 2b SIGLEC study has enrolled approximately 100 patients in each of the three study arms. This trial is designed to evaluate whether AVD-104 can slow the progression of GA, a leading cause of vision loss in older adults. Geographic atrophy affects over one million people in the United States alone, and is characterized by progressive and irreversible loss of photoreceptors and the underlying retinal pigment epithelium.
AVD-104: A Novel Approach to GA Treatment
AVD-104 is an engineered glycan (sialic acid) nanoparticle developed by Aviceda Therapeutics. It is designed to reduce inflammation by targeting self-pattern recognition receptors on overly activated retinal neutrophils, macrophages, and microglia, repolarizing them to their resolution state. This mechanism of action differentiates AVD-104 from other therapies that primarily target the complement system.
Clinical Significance and Next Steps
The completion of enrollment in the Phase 2b SIGLEC study marks a significant milestone for Aviceda Therapeutics and the GA treatment landscape. The results of this study will provide critical data on the potential of AVD-104 to address the unmet medical need for more effective GA therapies. The company has previously reported positive safety and early clinical efficacy data from Part 1 of the Phase 2/3 SIGLEC trial, showing substantial slowing of GA lesion growth and functional improvement in a majority of study subjects sustained at 3 months after a single injection of AVD-104.
Aviceda is also evaluating AVD-104 for the treatment of diabetic macular edema (DME) in the Phase 2 GLYCO trial. Topline results from this study are expected in Q2 2024.
