Belite Bio Completes Enrollment in the DRAGON II Clinical Trial of Tinlarebant for Stargardt Disease (STGD1)

Core Insights - Belite Bio has completed enrollment of 60 subjects in the Phase 2/3 DRAGON II clinical trial for tinlarebant, targeting Stargardt disease type 1 (STGD1) [1][2][7] - The trial is a global, 24-month, randomized, double-masked, placebo-controlled study involving participants aged 12 to 20 years from Japan, the United States, and the United Kingdom [2] - The company plans to submit a New Drug Application (NDA) to the FDA for tinlarebant in the first half of 2026 [3][7] Clinical Trial Details - The DRAGON II trial aims to evaluate the efficacy, safety, and tolerability of tinlarebant in adolescent patients with STGD1 [2] - Participants are randomized 1:1 to receive either tinlarebant or placebo [2] - The completion of enrollment reflects strong engagement from the Stargardt disease community [3] Drug Information - Tinlarebant is an oral therapy designed to reduce the accumulation of vitamin A-based toxins (bisretinoids) that cause retinal disease in STGD1 [4] - The drug works by modulating serum retinol binding protein 4 (RBP4) levels, thereby reducing bisretinoid formation [4] - Tinlarebant has received multiple designations, including Breakthrough Therapy Designation and Fast Track Designation in the U.S. [4] Company Overview - Belite Bio focuses on developing novel therapeutics for degenerative retinal diseases and specific metabolic diseases [5] - The company has completed a Phase 3 trial (DRAGON) in adolescent STGD1 subjects and is also evaluating tinlarebant in a Phase 3 trial (PHOENIX) for geographic atrophy [5] - The company is committed to advancing research for adolescents with Stargardt disease globally [3]