ONL Therapeutics, Inc. announced the first participant has been randomized in the company’s phase 2 GALAXY global clinical trial to evaluate the efficacy and safety of xelafaslatide (formerly ONL1204) in patients who have geographic atrophy (GA) associated with dry age-related macular degeneration (AMD).
According to a press release, Xelafaslatide is an investigational small molecule Fas inhibitor delivered via intravitreal injection that is designed to protect key retinal cells, including photoreceptors, from cell death that occurs across a range of retinal diseases and conditions, including GA associated with dry AMD.
According to ONL Therapeutics, Inc., GALAXY (NCT06659445) will enroll approximately 324 patients across sites in the United States (US), Canada, and the European Union. Specifically, the trial will build on data from a phase 1b study that demonstrated xelafaslatide to be generally safe and well tolerated with encouraging efficacy signals observed after 6 months. Xelafaslatide, will be studied across 3 experimental arms, including 2 dose levels and 2 treatment frequencies (every 12 weeks or every 24 weeks). The primary endpoint will be the rate of growth of the GA lesion area in patients treated with xelafaslatide vs sham, as assessed by fundus autofluorescence measured at 48 weeks.
ONL Therapeutics, Inc.'s later stage clinical development program for xelafaslatide includes a phase 2 study for the treatment of GA associated with AMD (NCT06659445) and a completed phase 2 study in the US for the treatment of macula-off retinal detachment (RD) (NCT05730218), a condition for which the compound has been granted orphan drug designation by the US Food and Drug Administration . The company says in a press release that it has also completed a phase 1b clinical trial in patients who have GA associated with AMD (NCT04744662), a phase 1b clinical trial in patients who have progressing open-angle glaucoma (NCT05160805), and a phase 1 clinical trial in macula-off RD patients at sites in Australia and New Zealand (NCT03780972). OM