Belite Bio, Inc.

DSMB Endorses Continuation of Phase 3 DRAGON Trial for Tinlarebant in Stargardt Disease

3 months ago

• Independent Data Safety Monitoring Board recommends proceeding with Belite Bio's Phase 3 DRAGON trial of Tinlarebant for Stargardt disease without modifications, maintaining the original 104-subject sample size. • Interim analysis reveals Tinlarebant demonstrates favorable safety profile with visual acuity stabilization in most subjects, showing less than three-letter score changes under both standard and low luminance conditions. • The pivotal global trial, spanning 11 jurisdictions, is expected to complete by Q4 2025, evaluating the first potential treatment for Stargardt disease with multiple regulatory designations worldwide.

Gilead's Trodelvy Receives FDA Breakthrough Therapy Designation for SCLC; Seladelpar Recommended for EU Approval

5 months ago

• The FDA granted Breakthrough Therapy Designation to Gilead's Trodelvy for extensive-stage small cell lung cancer (ES-SCLC) after platinum-based chemotherapy, based on promising results from the TROPiCS-03 study. • Gilead will collaborate with Terray Therapeutics to discover and develop novel, small molecule therapies across multiple targets, leveraging Terray's tNova platform. • The European Medicines Agency's CHMP recommended approval of Gilead's seladelpar for primary biliary cholangitis (PBC) in combination with UDCA or as monotherapy.

Belite Bio Doses First Patient in Phase 2/3 DRAGON II Trial of Tinlarebant for Stargardt Disease

8 months ago

• Belite Bio has dosed the first patient in the Phase 2/3 DRAGON II trial, evaluating Tinlarebant for Stargardt disease (STGD1) treatment. • The DRAGON II trial will assess Tinlarebant's efficacy, safety, and tolerability in approximately 60 adolescent STGD1 subjects across multiple sites. • Tinlarebant, an oral therapy, aims to reduce vitamin A-based toxins that contribute to retinal disease in STGD1 and advanced Dry AMD. • The trial includes sites in the U.S., U.K., and Japan, with data from Japanese subjects intended to support future NDA applications in Japan.