Belite Bio BLTE has initiated enrollment for the U.S. Phase 3 clinical trial of its lead asset LBS-008 in patients with Stargardt Disease (STGD1), a progressively blinding disease with no approved treatment.
The Phase 3 (DRAGON) trial is designed to evaluate the safety and efficacy of LBS-008 in adolescent STGD1 patients.
Tom Lin, Chairman and CEO, stated, ”STGD1 is the most common inherited retinal dystrophy causing blurring and/or loss of central vision in both adults and children. With over 30,000 STGD1 patients alone in the U.S., we have a treatment with the potential to address a large unmet need with a clear clinical pathway to bring hope to patients afflicted with this debilitating disease.”
STGD1 is the most common inherited retinal dystrophy (causing blurring or loss of central vision) in both adults and children. The disease is caused by a dysfunctional retina-specific gene.
The company understands that LBS-008 has the potential to be effective for the treatment of Dry AMD as well. A Phase 2/3 clinical trial for Dry AMD is expected to be initiated in the fourth quarter of 2022.
Dry AMD is a leading cause of vision loss in the United States.
LBS-008 has been granted fast track designation and rare pediatric disease designation (RPD) in the United States, and orphan drug designation (ODD) in both the United States and Europe for STGD1.
Price Action : Belite shares are trading around 17 percent higher at $26.30 on Monday at the time of publication.
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