Belite Bio(BLTE) Newsfilter·2025-02-27 07:00Core Insights - Belite Bio, Inc has announced that the Data Safety Monitoring Board (DSMB) has recommended the continuation of the Phase 3 "DRAGON" trial for Tinlarebant in adolescent Stargardt disease patients without modifications following an interim analysis [1][7] - The trial is expected to be completed by Q4 2025, including a three-month follow-up period [4][7] Trial Design and Recommendations - The DRAGON trial employs an adaptive sample size re-estimation to enhance statistical power based on treatment effects observed during the interim analysis [2] - The DSMB's recommendation indicates that an increase in sample size is not necessary, and they have advised submitting the data for further regulatory review [2] Safety and Efficacy Observations - Tinlarebant has shown a well-tolerated safety profile consistent with previous data, with visual acuity stabilized in most subjects, showing a mean change from baseline of less than three letter scores under both standard and low luminance conditions [3][4] - The primary efficacy endpoint of the trial is the growth rate of atrophic lesions, alongside safety and tolerability assessments [4][7] Regulatory Designations - Tinlarebant has received multiple designations, including Orphan Drug Designation in the U.S., Europe, and Japan, Rare Pediatric Disease designation, Fast Track designation in the U.S., and Sakigake (Pioneer Drug) designation in Japan [4][7] Company Overview - Belite Bio focuses on developing novel therapeutics for degenerative retinal diseases with significant unmet medical needs, including Stargardt disease and Geographic Atrophy in advanced dry age-related macular degeneration [6]