Enrollment begins in Switzerland as the company continues to activate clinical sites beyond the U.S. market
ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced that the first European participant has been randomized 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 U.S.
“Geographic atrophy remains one of the most devastating challenges in ophthalmology, and treatment options in Europe remain limited,” said David N. Zacks, M.D., Ph.D., chief scientific officer of ONL Therapeutics. “With its unique and differentiated mechanism of action targeting the Fas pathway, xelafaslatide has the potential to bring a much-needed neuroprotection therapy to patients facing this progressive, vision-threatening disease. Enrolling our first European patient in the GALAXY trial represents an important milestone in our effort to provide clinicians with potentially more effective and durable treatment options for their GA patients.”
“Activating GALAXY clinical sites across Europe while simultaneously advancing enrollment in the U.S. and Canada demonstrates our team’s capability to execute a complex, global trial,” said Penny Fleck, MT, MBA, chief development officer of ONL Therapeutics. “This achievement is a testament to the strength of our clinical development team and our unwavering commitment to delivering a safe and effective treatment option for patients with GA.”
GALAXY (NCT06659445) will enroll approximately 324 patients across sites in the U.S., 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 U.S. sites only.
