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Belite Bio Announces Start of LBS-008 Phase 3 Stargardt Disease Trial

Press release by Belite Bio

Lin BioScience’s subsidiary, Belite Bio, a clinical stage biopharmaceutical drug development company announced the initiation of Phase 3 clinical trial in Stargardt disease for tinlarebant (LBS-008), a First-in-Class oral small molecule RBP4 antagonist aimed to treat atrophic Age-related Macular Degeneration (commonly known as dry AMD) and Stargardt disease, an inherited juvenile form of macular degeneration. Since Stargardt patients suffer from progressive vision loss since childhood, they urgently need treatments as early as possible. LBS-008 entering Stargardt Phase 3 is an important development milestone for Belite Bio and at the same time, brings hope to Stargardt patients and their families.

Stargardt disease is an inherited juvenile form of macular degeneration, which affects 1 in 8,000-10,000 children. Some Stargardt patients suffer severe visual impairment by the age of 20, and currently there is no treatment available. The disease is caused by a mutation in the ABCA4 gene, which leads to the accelerated formation and accumulation of excess vitamin A toxic by-products known as A2E. A2E accumulates in the retina that cause progressive retinal cell death and permanent loss of vision.

LBS-008 has received US and EU orphan drug designation (ODD), and rare pediatric disease designation (RPD) from the FDA. LBS-008 has completed its Stargardt Phase 2 patient enrollment and initiated a global Phase 3 in Stargardt disease.

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