Key Takeaways

  • First European patient randomized in ONL Therapeutics’ global phase 2 GALAXY trial; enrollment planned across the U.S., Canada, and Europe (~324 patients)

  • Xelafaslatide, a first-in-class Fas pathway inhibitor, aims to provide a neuroprotective approach for geographic atrophy

  • Trial builds on positive phase 1b safety and early efficacy signals, with key endpoint measuring GA lesion growth at 48 weeks across multiple dosing regimens

ONL Therapeutics announced the randomization of the first European participant in its phase 2 GALAXY trial. The milestone marks the official expansion of the study into Europe, with the first patient enrolled at a clinical site in Switzerland.

GALAXY is a global phase 2 clinical trial evaluating the safety and efficacy of xelafaslatide (formerly ONL1204) in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The study aims to enroll approximately 324 patients across sites in Europe, Canada, and the United States.

“Geographic atrophy remains one of the most devastating challenges in ophthalmology, and treatment options in Europe remain limited,” said David N. Zacks, MD, PhD, chief scientific officer of ONL Therapeutics. “With its unique mechanism targeting the Fas pathway, xelafaslatide has the potential to offer a much-needed neuroprotective approach for patients facing this progressive, vision-threatening disease.”

The GALAXY trial will assess xelafaslatide across three experimental arms, including two dose levels and two dosing intervals—every 12 weeks and every 24 weeks—administered via intravitreal injection. The primary endpoint is the rate of growth of GA lesion area, measured by fundus autofluorescence (FAF) at 48 weeks. Patients will be followed for up to 72 weeks, with an active reference arm included for U.S.-based participants.

The study builds on encouraging data from a prior phase 1b trial, in which xelafaslatide was found to be generally safe and well tolerated, with early signals suggesting potential efficacy at 6 months.

Xelafaslatide is part of ONL Therapeutics’ broader clinical development program targeting multiple retinal diseases. In addition to the ongoing GA study, the therapy has been evaluated in phase 2 trials for macula-off retinal detachment—where it has received orphan drug designation from the FDA—as well as in earlier-stage studies for glaucoma and other retinal conditions.