Belite Bio Announces Completion of Enrollment in the Pivotal Global Phase 3 PHOENIX Trial Evaluating Oral Tinlarebant in Geographic Atrophy

Core Insights - Belite Bio has completed enrollment in the PHOENIX trial, a pivotal Phase 3 study evaluating Tinlarebant for geographic atrophy in dry age-related macular degeneration [1][2][3] Company Overview - Belite Bio is a clinical-stage biopharmaceutical company focused on developing therapeutics for degenerative retinal diseases, including Stargardt disease type 1 and geographic atrophy [5] - The company's lead candidate, Tinlarebant, is an oral therapy aimed at reducing retinal toxin accumulation and is currently in multiple clinical trials [5] Clinical Trial Details - The PHOENIX trial is a 24-month, randomized, double-masked, placebo-controlled, multicenter study conducted across several countries, including the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia [3] - The trial aims to evaluate the efficacy of Tinlarebant in slowing the growth of atrophic lesions, a key marker of disease progression in geographic atrophy [2][3] Market Need - Geographic atrophy is a progressive condition that severely impacts vision and quality of life, with no approved oral treatments currently available [2][4] - The completion of enrollment in the PHOENIX trial reflects a significant unmet medical need for patients suffering from this condition [2][4] Regulatory Designations - Tinlarebant has received several designations, including Rare Pediatric Disease designation, Fast Track Designation, and Breakthrough Therapy Designation in the United States, as well as Orphan Drug Designation in multiple regions [4]