Positive Early Results for AVD-104 in Phase 2/3 GA Trial

Aviceda Therapeutics, a biotech firm specializing in glyco-immune therapeutics, has reported favorable results from the initial segment of their Phase 2/3 clinical trial for a treatment named AVD-104. The medication, intended for patients with geographic atrophy (GA) due to age-related macular degeneration (AMD), demonstrated both safety and efficacy, with patients showing no serious adverse events related to the drug.

The trial's first part involved a single intravitreal injection of AVD-104 administered to 30 patients, who were then monitored for three months. The results indicated a significant reduction in GA lesion progression and functional improvements in vision, which were sustained over the observation period. Notably, the imaging biomarker for rapid disease progression, junctional zone hyperautofluorescence, was notably reduced in eyes treated with therapeutic doses of AVD-104.

Dr. David Callanan, Aviceda’s Chief Medical Officer, expressed enthusiasm over the visual and functional improvements observed and the rapid decrease in GA lesion growth rate, all with a positive safety profile. He anticipates the commencement of the trial's second part, where AVD-104's effectiveness over existing complement inhibition therapies will be further explored.

Mohamed Genead, Co-founder and CEO of Aviceda, highlighted the significance of AVD-104's dual mechanism of action, which addresses both macrophage/microglial- and complement-mediated inflammation. He believes this approach could revolutionize GA treatment by targeting the junctional zone, the leading edge of GA, where disease progression is most rapid.

The second part of the SIGLEC trial will be a more extensive study, enrolling approximately 300 patients to evaluate AVD-104 against an active comparator over a period of 12 months, with an option for an additional year. The primary goal will be to measure the difference in GA area growth rate between treated patients and the active comparator at 12 months.

Aviceda Therapeutics, through its proprietary HALOS™ nanotechnology platform, is advancing AVD-104, a glycan-coated nanoparticle with a dual mechanism of action that modulates key inflammatory pathways. The company is also developing a broad pipeline of products for various therapeutic areas, including oncology, immunology, neurology, and fibrosis.