Company: BLTE
Filing Date: 2025-01-27
Form Type: 424B7
Source: 0001104659-25-006367
Chunk: 29

Company: BELITE BIO, INC
Filing Date: 2025-01-27
Form: 424B7
Chunk 29
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 subjects in total and evaluated the safety, toxicity, pharmacokinetics, or PK, and pharmacodynamics, or PD, of Tinlarebant.

Following completion of the Phase 1 studies, an open-label, dose-finding Phase 1b/2 clinical trial in adolescent STGD1 subjects was initiated in Australia and Taiwan. The study design included two portions: the Phase 1b portion was a 1-month dose finding study which enrolled 11 adolescent STGD1 subjects; the Phase 2 portion was a 24 month extension of the Phase 1b portion in which the 11 STGD1 subjects completing in Phase 1b were enrolled.

Two additional adolescent STGD1 subjects were also enrolled, giving a total of 13 adolescent STGD1 subjects for the Phase 2 portion. Genotyping data showed that all 13 subjects harbored severe biallelic mutations which would predict pathogenicity. The PD data from the Phase 1b portion revealed that during repeated daily dosing, Tinlarebant produces a sustained mean RBP4 reduction of >70%, relative to baseline. A total of 12 subjects completed the Phase 2 portion of the study (1 subject was lost to follow

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up at Month 12). The 24-month data continued to support Tinlarebant’s safety profile and showed no growth of atrophic retinal lesions (referred to as definitely decreased autofluorescence or DDAF) in 5 of 12 subjects. In the 7 subjects showing DDAF lesion growth, the growth rate was significantly reduced when compared to historical control data obtained from adolescent STGD1 patients who participated in a 24-month natural history study known as ‘ProgStar’. Based on data from the Phase 1b/2 study, a Phase 3 clinical trial named “DRAGON” in adolescent STGD1 patients was initiated. This study, which is a global, multi-center, randomized, double masked, placebo-controlled study designed to evaluate the safety and efficacy of Tinlarebant in the treatment of adolescent STGD1 patients, has completed enrollment of 104 subjects. Interim analysis of the Phase 3 DRAGON trial is anticipated to be conducted by the Data and Safety Monitoring Board (DSMB) in early 2025.

To support the clinical development of Tinlarebant in GA, in addition to the foregoing Phase 1 and 1b/2 studies