The trial, sponsored by ONL Therapeutics, aims to enroll approximately 324 patients across sites in Europe, the United States, and Canada.

Key Takeaways

• Enrollment spans Europe, the US, and Canada, targeting ~324 GA patients in a randomized, double-masked, sham-controlled phase 2 program.
• Dosing compares two intravitreal dose levels given every 12 or 24 weeks; primary efficacy is GA lesion growth by fundus autofluorescence at 48 weeks, with follow-up to 72 weeks.
• Mechanistically, Fas receptor signaling inhibition is intended to reduce apoptosis and inflammatory cascades in the retina, providing a neuroprotective approach distinct from complement blockade.
• Early phase 1b experience (n=28) showed acceptable tolerability over 24 weeks and exploratory signals of slower lesion expansion, but sample size and analyses were hypothesis-generating.
• Clinical relevance hinges on whether lesion-growth reductions translate to functional outcomes, and whether extended dosing intervals can improve treatment burden versus approved C3/C5 inhibitors.

European investigators have begun enrolling patients in the phase 2 GALAXY trial evaluating xelafaslatide (formerly ONL1204), an investigational Fas pathway inhibitor, for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The first European participant was recently randomized at a clinical site in Switzerland, marking the start of the trial’s European recruitment phase in what is planned as a global, multicenter study.

The trial, sponsored by ONL Therapeutics, aims to enroll approximately 324 patients across sites in Europe, the United States, and Canada. Investigators will evaluate the safety and efficacy of intravitreal xelafaslatide for slowing GA lesion progression, a key clinical endpoint in therapeutic development for this advanced stage of AMD. If successful, the program could add a neuroprotective strategy to a treatment landscape that has only recently seen the first regulatory approvals targeting disease progression.

Phase 2 GALAXY Trial Design

GALAXY (NCT06659445) is a randomized, double-masked, sham-controlled phase 2 study evaluating 2 dose levels of xelafaslatide administered via intravitreal injection at either 12-week or 24-week intervals. The study’s primary endpoint is the rate of GA lesion growth compared with sham treatment, measured by fundus autofluorescence at 48 weeks. Follow-up assessments are planned through 72 weeks to evaluate the durability of treatment effects.¹

Read more or listen here: https://shorturl.at/67YEt

Source: Ophthalmology Times

The post ONL Therapeutics randomizes first European patient in phase 2 GA trial of Xelafaslatide appeared first on Macular Degeneration Association.