ONL Therapeutics, a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, has announced that the first European participant has been randomised in the company’s phase 2 GALAXY trial.
GALAXY is a global phase 2 clinical trial designed to evaluate the efficacy and safety of xelafaslatide (formerly ONL1204) in patients with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD).
This milestone, which took place 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 US.
GALAXY (NCT06659445) will enrol approximately 324 patients across sites in the US, Canada and Europe.
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. Additional timepoints will be measured out to 72 weeks, and an active reference arm will be applicable to patients at US sites only.
