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Belite Bio公布3期DRAGON试验结果显示Tinlarebant显著减少Stargardt病病变生长

2025-12-01 19:02

  • Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in a global Phase 3 trial for Stargardt disease, achieving a statistically significant p-value of 0.0033
  • Tinlarebant met the primary efficacy endpoint, demonstrating clinical benefit by significantly reducing the lesion growth rate by 36% compared to placebo, as measured by retinal imaging
  • Tinlarebant was well tolerated throughout the trial
  • Stargardt disease impacts more than 50,000 patients in the U.S.
  • Belite Bio plans to file an NDA with the US FDA in 1H 2026
  • Company will host a conference call and webcast today at 8:00 a.m. ET

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