Belite Bio Starts Enrollment In Pivotal Lead Asset Study In Inherited Eye Disease

Belite Bio Inc BLTE commenced enrollment for the U.S. Phase 3 trial of LBS-008 in patients with Stargardt Disease (STGD1), a progressively blinding disease with no approved treatment.
LBS-008 is an orally-available, small molecule retinol-binding protein 4 (RBP4) antagonist that selectively reduces the delivery of vitamin A (retinol) to the eye, leading to a reduction of toxic vitamin A byproducts (bisretinoids) that have been implicated in the onset and progression of STGD1.
Belite Bio is currently conducting a 2-year Phase 2 trial and a 2-year Phase 3 (DRAGON) trial of LBS-008 in adolescent STGD1 subjects.
Preliminary data from the Phase 2 trial at the first 6-month interval shows that 8 of the 13 patients (or 61.5%) recorded a gain in best-corrected visual acuity (BCVA) in at least one eye, including two patients who recorded a BCVA gain in both eyes.
Belite Bio expects the next data readout in Q4 of 2022.
The Phase 3 (DRAGON) trial plans to enroll approximately 60 patients.
Belite Bio plans to initiate a Phase 2/3 trial for Dry Age-related Macular Degeneration in Q4 of 2022.
Price Action: BLTE shares are up 16.5% at $26.30 on the last check Monday.