Belite Bio Submits Investigational New Drug (IND) Application to FDA for Approval to Proceed with LBS-008 Phase 3 Clinical Trial for the Treatment of Stargardt Disease

• LBS-008 (a/k/a Tinlarebant) is the Company’s orally administered tablet for the treatment of Stargardt disease (STGD1)
• There are currently no approved treatments for STGD1
• Approximately 30,000 patients in the U.S. suffer from STGD1
• A 2-year Phase 2 trial in adolescent STGD1 and a global Phase 3 trial in adolescent STGD1 are ongoing
• The Phase 3, Multicenter, Randomized, Double Masked, Placebo Controlled Study to Evaluate the Safety and Efficacy of TinlaRebant in the Treatment of StArGardt Disease in AdOlesceNt Subjects (DRAGON) trial has been approved for patient enrollment in the United Kingdom, Switzerland, Hong Kong, Taiwan, and Australia, and enrollment has commenced
• LBS-008, the Company’s lead asset, has been granted fast track designation, rare pediatric disease designation (RPD) in the U.S., and orphan drug designation (ODD) in the U.S. and Europe

Excerpt from the Press Release:

SAN DIEGO, July 19, 2022 (GLOBE NEWSWIRE) — Belite Bio, Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a San Diego based clinical stage biopharmaceutical drug development company targeting untreatable eye diseases, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to support Phase 3 development of LBS-008, the Company’s orally administered treatment for Stargardt Disease (STGD1), a rare genetic eye disease that causes progressive vision loss in children and adults.

LBS-008 is a small molecule retinol binding protein 4 (RBP4) antagonist that selectively reduces the delivery of vitamin A (retinol) to the eye leading to a reduction of toxic vitamin A byproducts (bisretinoids) that have been implicated in the onset and progression of STGD1. Sponsored by the NIH Blueprint program to treat non-neovascular age-related macular degeneration (dry AMD), LBS-008 is also endorsed by NIH as a promising first-in-class oral medication intended to slow or halt the progression of dry AMD, a disease which primarily affects the elderly and shares a similar pathophysiology as STGD1. There are currently no FDA approved treatments for STGD1 or dry AMD.

Dr. Tom Lin, Belite’s Chairman and CEO commented, “We are very pleased with LBS-008’s progress in the clinic. With the promising results from the Phase 2 trial in early-onset STGD1 subjects, we have initiated the global Phase 3 trial for LBS-008 and believe that we are on a clear clinical development pathway to accelerate and bring forward a promising treatment for STGD1 and dry AMD.”

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