Belite Bio presents results from a 24-month, Phase 2 study of Tinlarebant

Belite Bio presented final data from a 24-month, Phase 2 study of Tinlarebant in adolescent STGD1 at the American Association of Ophthalmology Annual Meeting. “Tinlarebant’s final Phase 2 results represent a significant milestone for Belite Bio and provide additional foundational support for the work being conducted across our trials,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “The final Phase 2 data continue to demonstrate Tinlarebant’s safety profile and show a sustained lower DDAF lesion growth compared to ProgStar participants over the two-year treatment period. We hope to see similar data in the ongoing Phase 3 DRAGON study, further supporting Tinlarebant as a promising oral treatment for STGD1 patients.” Key study findings: Tinlarebant was safe and well-tolerated with no withdrawals due to adverse events. Retinal imaging showed that 5 of 12 subjects remained free of atrophic retinal lesions after 24 months of Tinlarebant treatment. A comparison of the 24-month DDAF lesion growth between Tinlarebant-treated subjects and ProgStar participants possessing similar baseline characteristics showed a sustained lower DDAF lesion growth in Tinlarebant-treated subjects over the 24-month treatment period. Visual acuity was stabilized in majority of subjects during the study with a mean loss of five letters following 24 months of treatment.