Belite Bio has submitted an application to the Taiwanese Food and Drug Administration for initiating a Phase III clinical trial of tinlarebant (LBS-008) for the treatment of geographic atrophy (GA).
The international Phase III, multicentre, randomised, double-masked, placebo-controlled study of tinlarebant to explore (PHOENIX) will evaluate the safety and efficacy of GA treatment.
Tinlarebant will be evaluated in patients with GA associated with Dry Age-related Macular Degeneration (Dry AMD).
Nearly 430 subjects enrolled will be randomised into a 2:1 ratio to receive tinlarebant or placebo.
Tinlarebant is orally administered for slowing disease progression in patients affected with Stargardt Disease (STGD1) and GA in advanced dry AMD.
It reduces the accumulation of bisretinoids, byproducts of vitamin A, leading to death of retinal cell and progressive loss of central vision.
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It will also maintain levels of serum retinol-binding protein 4 (RBP4) that helps in transporting the protein from the liver to the eye.
The PHOENIX study has already been initiated in the US, as part of an approval received from the FDA last November.
The therapy has also received orphan drug designation in both Europe and the US and rare pediatric disease and fast track designations in the US.
STGD1 is said to be the most common inherited retinal dystrophy causing blurring or loss of central vision in children and adults. There are currently no FDA-approved treatments for this disease.