Pharma Focus Asia

Belite Bio Submits Tinlarebant Phase 3 GA Clinical Trial Application to Swissmedic

Saturday, October 07, 2023

Belite Bio has announced its submission to Swissmedic for the initiation of the Phase 3 clinical trial of Tinlarebant, known as the PHOENIX study, in Switzerland.

The PHOENIX study is a Phase 3 clinical trial that will be conducted at multiple centres. It will be double-masked, placebo-controlled, randomised, and will employ a fixed-dose approach. The primary goal of this clinical study is to assess the efficacy and safety of Tinlarebant in patients who have GA associated with Dry AMD. 

Tinlarebant is a novel oral therapy aimed at reducing the accumulation of toxins in the eye that are responsible for causing Stargardt disease type 1 (STGD1) and contributing to geographic atrophy (GA), which is advanced dry age-related macular degeneration (AMD). These toxins are produced as by-products of the visual cycle, which relies on the supply of vitamin A (retinol) to the eye.

Tinlarebant works by reducing and maintaining the levels of serum retinol binding protein 4 (RBP4), the primary carrier protein responsible for transporting retinol from the liver to the eye. By regulating the amount of retinol that enters the eye, Tinlarebant effectively reduces the formation of these harmful toxins.

Tinlarebant has received designations in the United States, including fast track designation, rare paediatric disease designation, and in both the U.S. and Europe, orphan drug designation for the treatment of STGD1.

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