ONL Therapeutics has randomized the first patient in its global phase 2 GALAXY trial evaluating xelafaslatide (formerly ONL1204) for the treatment of geographic atrophy (GA) associated with dry age-related macular degeneration (AMD). The study will assess the efficacy and safety of the investigational small molecule Fas inhibitor, designed to protect retinal cells such as photoreceptors from degeneration.

The GALAXY trial will enroll approximately 324 patients across the United States, Canada, and the European Union. It builds on prior data showing that xelafaslatide was generally safe and well tolerated, with signs of efficacy over 6 months. Patients will receive 1 of 2 doses administered every 12 or 24 weeks, with GA lesion growth measured at 48 weeks by fundus autofluorescence. Additional timepoints will be measured out to 72 weeks, and an active reference arm will be applicable to patients at US sites only.

Xelafaslatide is the newly established nonproprietary name for ONL1204 ophthalmic solution, following approval from the World Health Organization and the United States Adopted Names Council, the company said in a press release. RP