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

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  • 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.
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