SRK-181 - (DRAGON)

July 20, 2026: Belite Bio, Inc. (NASDAQ: BLTE) reported additional positive secondary endpoint data from its Phase 3 DRAGON trial of tinlarebant (LBS-008) in Stargardt disease type 1 (STGD1), presented July 18, 2026 in an oral session at the ASRS 2026 Annual Meeting in Montréal. Quantitative autofluorescence (qAF), a marker of toxic bisretinoid accumulation, diverged between arms: at month 25, tinlarebant-treated subjects had qAF stable to slightly decreased (~2% from baseline) versus an approximate 20% increase from baseline on placebo.

The company reiterated previously announced topline results: DRAGON (104 subjects, 2:1 randomization) met its primary endpoint, showing a statistically significant, clinically meaningful 35.7% reduction in retinal lesion growth rate (definitely decreased autofluorescence, DDAF) versus placebo; tinlarebant was well tolerated. Belite Bio also said its New Drug Application to the FDA for tinlarebant has been completed and noted ongoing development in Phase 2/3 DRAGON II (STGD1) and Phase 3 PHOENIX (geographic atrophy).