22 May 2018 - - US-based tissue factor biology specialist Iconic Therapeutics has enrolled the first patient in its second Phase 2 study of Icon-1 administered intravitreally both in combination with and as treatment after anti-vascular endothelial growth factor (anti-VEGF) therapy, the company said.
The dose exploration and continuation option (DECO), being conducted at eight clinical centers in the US, is recruiting patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) to generate additional clinical data with a higher dose of ICON-1 than previously evaluated.
The randomised, open-label DECO study is expected to recruit approximately 20 patients including those 50 years of age or older who are newly diagnosed with treatment-naïve CNV secondary to AMD.
The primary assessment will be the change in CNV size at month 9 compared to baseline in the study eye, and secondary endpoints include the change in best corrected visual acuity over time, and the duration of treatment-free periods over time.
Icon-1 is a fusion protein that binds to tissue factor overexpressed in the retina and the CNV of AMD patients. Iconic first evaluated Icon-1 in a single dose, 18-subject Phase 1 clinical trial in neovascular AMD, which showed tolerability for intravitreal injection in patients with wet AMD and preliminary evidence of potential biologic activity.
Iconic Therapeutics is a clinical stage biopharmaceutical company dedicated to translating an understanding of the role of tissue factor biology to new therapeutics for retinal disease and cancer.