Soligenix reaches agreement with EMA on second HyBryte trial

Soligenix has received agreement from the European Medicines Agency – EMA – on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte in the treatment of cutaneous T-cell lymphoma – CTCL – patients with early-stage disease. This confirmatory 18-week study is targeted to begin patient enrollment by the end of 2024 with top-line results anticipated in the second half of 2026. The confirmatory study, called FLASH2, replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study. In the first Phase 3 study, a treatment response of 49% was observed in patients completing 18 weeks, or 3 cycles, of therapy. In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion-exclusion criteria. HyBryte has received orphan drug and fast track designations from the FDA, as well as orphan designation from the EMA.