BRINGING HEALTH INSIGHT

TREAT THE
UNTREATABLE

Our pipeline of novel therapies, which is built on our RBP4 (Retinol Binding Protein 4) IP Portfolio, is focused on meeting the unmet needs of patients suffering from blindness, liver disease and diabetes.

Novel Therapy for

UNMET MEDICAL NEED

Belite Bio™ is a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases with significant unmet medical needs, such as atrophic age-related macular degeneration (AMD), commonly known as Geographic Atrophy (GA) in advanced dry AMD and autosomal recessive Stargardt disease, type 1, or STGD1.

Our lead candidate Tinlarebant, developed from our RBP4 intellectual property portfolio, is a novel oral therapy which is intended to reduce the accumulation of toxins in the eye that cause STGD1 and contribute to GA. We have completed a two-year Phase 2 study of Tinlarebant in adolescent STGD1 subjects, and are currently conducting a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects and a Phase 3 study (PHOENIX) in subjects with GA. Tinlarebant has obtained Orphan Drug Designation in the United States, Europe, and Japan, and has been granted the Rare Pediatric Disease (RPD) designation and the Fast Track Designation in the US and Sakigake (Pioneer Drug) Designation in Japan.

MEET THE TEAM

Tinlarebant

LBS-008

Bringing Hope to

INCURABLE BLINDNESS

Dry AMD / Stargardt Disease

PHASE 3

DETAILS

LBS

009

Blocking the Path to

METABOLIC DISEASE

Non-Fatty Liver Disease / Type 2 Diabetes

PRECLINICAL

DETAILS
i
Patient Registry

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Tinlarebant (LBS-008) – Phase 3 trial for Geographic Atrophy (the “Phoenix” trial)

Recruitment Status : Recruiting
This trial is a phase 3, multicenter, double-masked, placebo-controlled, randomized, fixed-dose clinical study designed to evaluate the efficacy and safety of tinlarebant in patients with Geographic Atrophy associated with Dry AMD.
VIEW CLINICAL TRIAL INFORMATION

Tinlarebant (LBS-008)-Phase 1b and Phase 2/3 trial for Stargardt Disease (the “DRAGON II” trial)

Recruitment Status: Recruiting
The DRAGON II trial is a combination of phase 1b open-label study to evaluate the pharmacokinetics and pharmacodynamics of Tinlarebant in Japanese adolescent STGD1 subjects and a phase 2/3, multicenter, double-masked, placebo-controlled, randomized study designed to evaluate the efficacy, safety and tolerability of Tinlarebant in adolescent STGD1 subjects.
VIEW CLINICAL TRIAL INFORMATION

Tinlarebant (LBS-008) – Phase 3 trial for Stargardt Disease (the “Dragon” trial)

Recruitment Status : Active: not recruiting

This trial is to assess the efficacy and safety of Tinlarebant in adolescent subjects with childhood-onset Stargardt Disease.

VIEW CLINICAL TRIAL INFORMATION

Tinlarebant (LBS-008) – Phase 1b/2 trial for Stargardt Disease

Status : Completed

This Phase 1b trial is to identify the optimal dose of Tinlarebant in adolescent subjects with childhood-onset Stargardt Disease. The Phase 1b trial is extended to a two year Phase 2 trial in assessing the safety and efficacy of Tinlarebant in adolescent subjects with childhood-onset Stargardt Disease.

VIEW CLINICAL TRIAL INFORMATION