Belite Bio Reports Additional Positive Secondary Endpoint Data from Phase 3 Tinlarebant Trial in Stargardt Disease Type 1 at ASRS 2026
Belite Bio, Inc (NASDAQ:
BLTE), a clinical-stage drug development company, has announced additional positive secondary endpoint data from its Phase 3 DRAGON trial of tinlarebant in Stargardt disease type 1 (STGD1). The findings were presented in an oral session at the American Society of Retina Specialists (ASRS) 2026 Annual Meeting in Montréal, Canada, on July 18, 2026.
The Phase 3 DRAGON trial enrolled 104 subjects worldwide and met its primary efficacy endpoint, demonstrating a statistically significant 35.7% reduction in the growth rate of retinal atrophic lesions, measured as definitely decreased autofluorescence (DDAF), compared with placebo over 24 months. Tinlarebant was well tolerated throughout the trial.
The newly reported secondary endpoint data focused on quantitative autofluorescence (qAF), a biomarker of toxic bisretinoid accumulation. At month 25, qAF values in tinlarebant‑treated subjects remained stable to slightly decreased from baseline (about 2%), while placebo‑treated subjects showed an approximately 20% increase in qAF, indicating a significant divergence between groups and supporting tinlarebant’s mechanism of slowing disease progression.
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