USFDAJul 20, 2026, 08:03 AM
Belite Bio Completes NDA for Tinlarebant; Phase 3 Data Positive
AI Summary
Belite Bio announced the completion of its New Drug Application (NDA) to the U.S. FDA for tinlarebant, a treatment for Stargardt disease type 1 (STGD1). The company also reported additional positive secondary endpoint data from its Phase 3 DRAGON trial, presented at the ASRS 2026 Annual Meeting. Quantitative autofluorescence (qAF) showed a marked divergence, with treated subjects' qAF remaining stable or slightly decreasing, while placebo subjects experienced an approximate 20% increase. This reinforces the previously announced primary endpoint success, which demonstrated a 35.7% reduction in retinal lesion growth.
Key Highlights
- New Drug Application (NDA) for tinlarebant completed with the U.S. FDA.
- Phase 3 DRAGON trial met primary efficacy endpoint.
- Tinlarebant showed a 35.7% reduction in retinal lesion growth rate.
- Treated subjects' quantitative autofluorescence (qAF) remained stable to slightly decreased (approx. 2%) from baseline.
- Placebo-treated subjects showed an approximate 20% increase in qAF from baseline.
- Tinlarebant was well tolerated throughout the trial.
- The Phase 3 DRAGON trial enrolled 104 subjects across 11 jurisdictions.
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