Belite Bio Receives FDA Fast Track Designation For LBS-008

SAN DIEGO, May 03, 2022 (GLOBE NEWSWIRE) — Belite Bio, Inc (the “Company”) (Nasdaq: BLTE),  a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, such as atrophic Age-related Macular Degeneration (dry AMD) and Stargardt disease (STGD1), and metabolic diseases, today announced that LBS-008, an orally administered tablet, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of STGD1. This decision was based upon FDA’s review of non-clinical data and preliminary clinical data from studies of LBS-008.

“We are delighted that LBS-008 has received FDA Fast Track Designation. STGD1 is a terrible retinal disease with the potential to severely affect the vision of afflicted patients and there are currently no approved treatments,” said Dr. Tom Lin, the Company’s Chairman and CEO. “At present, we are conducting a Phase 3 clinical trial in order to bring to market a treatment that will halt or slow the progression of STGD1. Additionally, we are evaluating our plan to launch a Phase 2/3 trial in Dry AMD in 2022. Dry AMD is a disease which shares a similar underlying pathophysiology with STGD1 and is a leading cause of central vision loss in people over 50.”

The Company expects the next near-term data readout in its STGD1 Phase 2 trial to occur in the last quarter of this year when all subjects have completed 12 months of treatment.

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