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 eye, slowing DAF lesion growth by 33.7% (study) & 32.7% (fellow), with decreased RBP4 by mean of ~80% on 5mg with recovery to 84% of baseline post-treatment
- Additionally, the company is planning to engage regulatory authorities to discuss next steps & submit NDA to the FDA in the H1’26
Ref: Belite Bio | Image: Belite Bio | Press Release
Related News: Belite Bio Reports the MHRA’s CMA Application Acceptance for Tinlarebant to Treat Stargardt Disease
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