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Wednesday / April 17.
HomeminewsStargardt Oral Therapy Fast-Tracked

Stargardt Oral Therapy Fast-Tracked

LBS-008, a novel oral therapy that prevents the build-up of toxins in the eye that cause Stargardt disease (STGD1) and contribute to dry agerelated macular degeneration (dry AMD), has been granted Fast Track Designation by the United States Food and Drug Administration (FDA) for the treatment of STGD1. The decision was based on FDA’s review of non-clinical data and preliminary clinical data from studies of LBS-008.

Developed by Belite Bio, a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, LBS-008 works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), a carrier protein that transports retinol to the eye. By modulating the amount of retinol entering the eye, LBS- 008 reduces the formation of toxins which have been implicated in STGD1 and dry AMD, to maintain the health of retinal tissues.

“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.”

The next near-term data readout of Belite Bio’s STGD1 Phase 2 trial is expected in the last quarter of 2022 when all subjects have completed 12 months of treatment.