Belite Bio, Inc. (BLTE) announced that the U.S. FDA has granted Breakthrough Therapy Designation for Tinlarebant for the treatment of Stargardt disease based on the
previously reported interim data from the ongoing Phase 3 DRAGON trial. The designation is based on the phase 3 DRAGON trial interim analysis results demonstrating Tinlarebant's efficacy and favorable safety profile. There are currently no approved treatments for Stargardt disease.
Hendrik Scholl, Chief Medical Officer of Belite Bio, said: "We look forward to continuing to evaluate Tinlarebants safety and efficacy as the DRAGON trial progresses."
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