ONL Therapeutics Inc, a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, announced on Monday that the first European participant has been randomised in the company's Phase 2 GALAXY trial of xelafaslatide (formerly ONL1204).

GALAXY is a global Phase 2 clinical trial designed to evaluate the efficacy and safety of xelafaslatide in patients with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD).

ONL said that this milestone, at a clinical trial site in Switzerland, marks the beginning of European participation in the GALAXY trial and represents another key step toward the company's goal of enrolling approximately 324 patients across Europe, Canada and the United States.

The trial seeks to build on data from a Phase 1b study that demonstrated xelafaslatide to be generally safe and well tolerated with encouraging efficacy signals observed after six months. Xelafaslatide, which is delivered via intravitreal injection, will be studied across three experimental arms, including two dose levels and two treatment frequencies (every 12 weeks or every 24 weeks). The primary endpoint is the rate of growth of the GA lesion area in patients treated with xelafaslatide versus sham as assessed by fundus autofluorescence (FAF) measured at 48 weeks.