Soligenix gets EMA agreement on confirmatory Phase 3 design for HyBryte in CTCL

SOLIGENIX, INC.

EMA agreed on key design for FLASH2: double-blind, placebo-controlled, 18-week continuous treatment.
Study to enroll ~80 early-stage CTCL patients in US and Europe; enrollment targeted by end of 2024.
Primary endpoint: ≥50% reduction in mCAILS score at Week 18; top-line results expected H2 2026.
FLASH2 replicates first Phase 3 design but extends continuous treatment without breaks.
Discussions with FDA on US development path remain ongoing; company prioritizes EMA pathway.

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