10:10 AM EDT, 03/22/2024 (MT Newswires) -- Belite Bio ( BLTE ) said Friday that it has completed the submission to Japan's Pharmaceuticals and Medical Devices Agency to start a clinical trial of its Tinlarebant product candidate in patients with Stargardt Disease.

The company said the planned trial is a combination of a phase 1b study to evaluate the pharmacokinetics and pharmacodynamics of Tinlarebant and a phase 2/3 global study to evaluate the efficacy, safety and tolerability of the product candidate. Belite Bio ( BLTE ) plans to enroll about 60 patients of 12 years old to 20 years old, including 10 Japanese patients, for the phase 2/3 study of the trial.

Belite Bio ( BLTE ) said data from the Japanese subjects in the study will be used to facilitate future new drug applications in Japan.

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