Belite Bio Seeks FDA Clearance For Late-Stage Genetic Eye Disease Study

Belite Bio BLTE submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to support Phase 3 development of its lead asset LBS-008 for treatment of Stargardt Disease (STGD1).

The Stargardt Disease (STGD1) is a rare genetic eye disease that causes progressive vision loss in children and adults.

LBS-008 is a novel oral therapy that prevents the accumulation of toxic byproducts of vitamin A which are known to cause STGD1 and contribute to dry AMD.

Dr. Tom Lin, Belite's Chairman and CEO, stated, "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."

LBS-008 has been granted Fast track designation, Rare pediatric disease designation (RPD) in the United States and Orphan drug designation (ODD) in the U.S. as well as in the European Union.

Price Action : Belite Bio shares closed Tuesday’s trading higher 5 percent at $43.65