Belite Bio Inc. (BLTE), a clinical-stage drug development company, on Tuesday announced initiation of a rolling new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA), for Tinlarebant in treating Stargardt disease.
Stargardt disease type 1 (STGD1) is a rare, inherited retinal disorder caused by a mutation in the ABCA4 gene. The progressive disease often begins in adolescence, and is marked by the accumulation of vitamin A-based toxins (bisretinoids), leading to retinal disintegration.
Tinlarebant (LBS-008) was developed for the treatment of STGD1 by reducing and maintaining levels of serum retinol-binding protein 4 (RBP4), the sole carrier protein from the liver to the eye. The drug thus regulates the formation of bisretinoids, preventing progression of the disease. Results from the Phase 3 DRAGON trial on adolescents with STGD1 will contribute to the NDA submission.
Tinlarebant was previously granted a breakthrough therapy, fast track, rare pediatric disease, and orphan drug designation in the U.S. Europe and Japan, in addition to a Sakigake designation in Japan. It is currently being evaluated in the Phase 2/3 DRAGON II trial for adolescent subjects with STGD1, and in the Phase 3 PHOENIX trial for treating geographic atrophy (GA) in age-related macular degeneration.
The company expects to complete the rolling NDA submission by the second quarter of 2026.
BLTE closed Tuesday at $165.23, down 0.12%.
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