Belite Bio, Inc. Completes Enrollment in Pivotal Global Phase 3 Dragon Trial Evaluating Oral Tinlarebant for Stargardt Disease
July 24, 2023 at 06:07 am EDT
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Belite Bio Inc. announced that enrollment of its pivotal global Phase 3 "DRAGON" trial for patients with Stargardt Disease (STGD1) has completed. Tinlarebant is an oral, once daily retinol binding protein 4 (RBP4) antagonist designed to lower levels of ocular vitamin-A based toxins implicated in STGD1. Professor Michel Michaelides, the Principal Investigator and the Chief Investigator of the DRAGON trial from Moorfields Eye Hospital in the United Kingdom, one of the top recruiting sites globally, added that, ?It has been a pleasure and privilege to be one of the recruiting sites for this promising Phase 3 DRAGON trial. The sustained slowing of disease progression demonstrated in the 18-month Phase 2 trial for patients with STGD1 is highly encouraging, and further reinforces company's belief in the transformative potential of Tinlarebant to be the first FDA-approved treatment option for STGD1.?
The pivotal Phase 3 DRAGON trial is a randomized, double-masked, placebo-controlled, global and multi-center study, designed to evaluate the safety and efficacy of Tinlarebant in adolescent STGD1 patients. The DRAGON trial has global sites in 11 countries, including the U.S., the United Kingdom, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan, and Australia. 90 patients have been enrolled in this study with a 2:1 randomization (active:placebo). The primary efficacy endpoint is slowing of lesion growth rate, along with the assessment of safety and tolerability. Tinlarebant has been granted Fast Track Designation and Rare Pediatric Disease Designation in the U.S., and Orphan Drug Designation in both the U.S. and Europe for STGD1. Topline data for Tinlarebant in the Phase 2 STGD1 study is expected in the fourth quarter of 2023 and the interim data for the Phase 3 DRAGON trial is expected by mid-2024.
In addition, Belite plans to have the first patient enrolled in the 2-year Phase 3 study (PHOENIX) of Tinlarebant in Geographic Atrophy (GA) in the third quarter of 2023.
Belite Bio, Inc is a clinical-stage biopharmaceutical drug development company. The Company is focused on advancing novel therapeutics targeting retinal degenerative eye disease, such as atrophic age-related macular degeneration (AMD), and autosomal recessive Stargardt disease type 1 (STGD) both of which progressively lead to permanent blindness, and metabolic diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), type 2 diabetes (T2D), and gout. Its lead product candidate, LBS-008 as an oral daily treatment for STGD1 and Geographic Atrophy patients. In STGD1, it is developing LBS-008 as once-a-day tablet treatment to target Retinol binding protein 4 (RBP4) by disrupting vitamin A (retinol) binding to RBP4 which leads to reduced delivery of retinol to the eye and reduced accumulation of toxic vitamin A by-products. Its product candidate also includes LBS-009 an anti-RBP4 oral therapy targeting liver disease, including NAFLD, NASH, and T2D.
BELITE BIO, INC 
