Belite Bio Unveils Phase 3 DRAGON Trial Results Showing Tinlarebant Significantly Reduces Stargardt Disease Lesion Growth
Benzinga Newsdesk 11 months ago
News
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 0.0033Tinlarebant met the primary efficacy
- 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