BLTE - Belite Bio adds 15% as pivotal trial for lead asset starts in U.S.
- Recently IPO’d Belite Bio, Inc ( NASDAQ: BLTE ) ended a four-day selloff on Monday to climb ~15% after the biopharma company announced the enrollments of its pivotal U.S. Phase 3 clinical trial for lead candidate LBS-008 in patients with eye disorder Stargardt Disease (STGD1).
- STGD1 has no FDA-approved therapies, and it is the commonest inherited retinal dystrophy that can lead to blurring and/or loss of central vision.
- LBS-008, an orally administered tablet, is currently undergoing a 2-year Phase 2 trial and a 2-year Phase 3 (DRAGON) trial involving adolescents with STGD1.
- The company plans to enroll about 60 subjects in the Phase 3 trial which is currently underway in the U.S., U.K., Germany, Belgium, Switzerland, Hong Kong, Taiwan, and Australia.
- In Q4 2022, BLTE expects to launch a Phase 2/3 trial designed to evaluate the potential of LBS-008 in non-neovascular age-related macular degeneration (Dry AMD), another eye condition with no FDA-approved therapies.
- Read more about BLTE’s upcoming milestones.
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Belite Bio adds 15% as pivotal trial for lead asset starts in U.S.