Soligenix, Inc. announced on December 16, 2024, the opening of patient enrollment for its confirmatory Phase 3 study, FLASH2, evaluating HyBryte™ (synthetic hypericin) for the treatment of early-stage cutaneous T-cell lymphoma (CTCL). This pivotal trial builds upon previous statistically significant Phase 3 results and supportive studies.
The FLASH2 study is a randomized, double-blind, placebo-controlled, multicenter trial designed to enroll approximately 80 subjects with early-stage CTCL in both the United States and Europe. The primary efficacy assessment will occur at the end of 18 weeks of continuous treatment.
Top-line results from the FLASH2 study are anticipated in the second half of 2026. The initiation of this trial is a critical step towards potential regulatory approval and commercialization of HyBryte™, which offers a novel photodynamic therapy utilizing safe visible light.
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