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Belite Bio Reports Topline P-III (DRAGON) Trial Data on Tinlarebant for Stargardt Disease Type 1 (STGD1)

Shots: Trial assessed tinlarebant (5mg, QD, PO; n=69) vs PBO (n=35) in 104 STGD1 pts (12-20yrs.), meeting its 1EP of 36% reduction in lesion growth per retinal imaging, quantified as 35.7% using the pre-specified MMRM model & confirmed at 35.4% with a post-hoc autoregressive-MMRM analysis Trial also showed reduced lesion growth rate by 33.6% in fellow…
16 hours ago

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Belite Bio Reports the MHRA’s CMA Application Acceptance for Tinlarebant to Treat Stargardt Disease

Shots: The UK’s MHRA has accepted a conditional marketing authorization (CMA) application for Tinlarebant to treat Stargardt disease CMA was based on the interim results from P-III (DRAGON) trial assessing Tinlarebant vs PBO in 104 adolescents with Stargardt disease across 11 jurisdictions, incl. the US, UK, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan,…
November 3, 2025

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Belite Bio
NEWS

Belite Bio Reveals Interim P-III (DRAGON) Trial Data of Tinlarebant for Adolescent Stargardt Disease

Shots: Belite Bio has reported 1yr. interim data from P-III (DRAGON) trial assessing tinlarebant vs PBO in adolescent stargardt disease pts (n=104). Completion expected in Q4’25 with DSMB recommending data submission for regulatory review The global Phase III trial utilized an adaptive sample size re-estimation design to evaluate atrophic lesion growth rate, safety & tolerability…
February 27, 2025

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