Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 45

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 45
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bant (5 mg orally, daily) was well tolerated in adolescent STGD1 patients. No drug or trial discontinuation due to non-ocular adverse events. There were 4 drug discontinuations that were related to the treatment. Xanthopsia and delayed dark adaptation are the most common drug related ocular adverse events. The majority of xanthopsia, delayed dark adaptation, and night vision impairment were mild, and most resolved during the trial. Headaches were the most commonly reported treatment-related non-ocular adverse event.

Phase 2/3 Clinical Trial in STGD1

In addition to the completed Phase 3 DRAGON clinical trial, we are conducting a clinical trial of Tinlarebant in adolescent STGD1 patients aged 12 to 20 years old in Japan, the United States and the United Kingdom (“DRAGON II”). The DRAGON II trial is a combination of a Phase 1b open-label study to evaluate the pharmacokinetics and pharmacodynamics of Tinlarebant in adolescent Japanese STGD1 subjects and a 24‑month, Phase 2/3, multi-center, randomized, double-masked, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of Tinlarebant. We have completed the Phase 1b PK/PD portion of DRAGON II and have dosed the first patient in the Phase 2/3 portion of the trial, which has a target enrollment of approximately 60 subjects, including approximately 10 Japanese subjects. The data from Japanese subjects is intended to facilitate future NDA applications in Japan.

Phase 1b/2 Clinical Trial in STGD1

We initiated an open-label, dose-finding Phase 1b/2 clinical trial in adolescent STGD1 patients in mid-2020 in Australia and Taiwan and have completed this trial. The study design includes two portions: Phase 1b and Phase 2. We have completed the Phase 1b portion of this study in 11 adolescent STGD1 subjects which has extended into a two-year, Phase 2 study with 13 adolescent STGD1 subjects in Australia and Taiwan. As of the date of this prospectus supplement, data is available for the 11 subjects who have completed the Phase 1b portion and for the 12 subjects who have completed the 24-month of treatment.

The Phase 1b portion is a dose-finding study designed to determine the optimal dose of Tinlarebant and to evaluate safety, tolerability, PK and