Belite Bio has received approval from the Taiwan Food and Drug Administration (TFDA) to initiate the Phase III PHOENIX study of Tinlarebant (LBS-008) tablet for the treatment of geographic atrophy (GA).

The fixed-dose, randomised, double-masked, placebo-controlled study intends to assess the safety and efficacy of the orally administered Tinlarebant in patients with GA associated with Dry Age-related Macular Degeneration (Dry AMD).

Nearly 430 subjects will be enrolled and randomised in a 2:1 ratio to receive Tinlarebant or placebo.

In an ongoing two-year Phase II study in adolescents, atrophic retinal lesions were found to be reduced in Stargardt Disease (STGD1) patients administered with Tinlarebant. The treatment was compared to a natural history study of the disease (ProgStar).

In addition, a continued trend of slowing expansion of autofluorescence was observed.

The company is also enrolling subjects for its Phase III DRAGON study of Tinlarebant in adolescent STGD1 patients.

Tinlarebant has been developed for reducing the accumulation of vitamin A-based toxins (bisretinoids), which cause STGD1 and contribute to dry AMD.

It reduces the serum retinol-binding protein 4 (RBP4) level, a carrier protein that delivers retinol from the liver to the eye.

The PHOENIX study of Tinlarebant has already been initiated in the US.

The therapy has also received Rare Pediatric Disease Designation and Fast Track Designation in the US, and Orphan Drug Designation in both Europe and the US for the treatment of STGD1.