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Belite Bio, Inc (NASDAQ:BLTE), a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases which have significant unmet medical needs, today announces the approval from Swissmedic for the Phase 3 clinical trial of Tinlarebant in Geographic Atrophy, or the PHOENIX study. The trial will initiate after Swissmedic requested protocol amendment specific to Switzerland has been made.
Tinlarebant (a/k/a LBS-008) is Belite Bio’s orally administered tablet intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD) A 2-year global Phase 3 trial in adolescent STGD1 (the “DRAGON” study) and a 2-year global Phase 3 trial in GA (the “PHOENIX” study) are ongoing In a 2-year Phase 2 STGD1 trial, Tinlarebant was safe and well-tolerated in all subjects, and a comparison of the DDAF lesion growth between Tinlarebant-treated subjects and the natural history ProgStar participants possessing similar baseline characteristics (aged ≤18 years) showed a sustained lower DDAF lesion growth in Tinlarebant-treated subjects (p<0.001)
Posted In: BLTE
