Soligenix Achieves Important Safety Milestone in its Confirmatory Phase 3 Clinical Trial of HyBryte™ for the Treatment of Cutaneous T-Cell Lymphoma

Core Insights - Soligenix, Inc. is progressing with its confirmatory Phase 3 FLASH2 study for HyBryte™ in treating cutaneous T-cell lymphoma (CTCL), with no safety concerns reported by the Data Monitoring Committee [1][2] - The study aims to enroll approximately 80 patients and is on track for an enrollment update in Q4 2025, with an interim efficacy analysis expected in the first half of 2026 [1][2] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, particularly through its Specialized BioTherapeutics segment [15] - The company is also involved in developing other products, including treatments for psoriasis and inflammatory diseases [15][16] Product Details - HyBryte™ (SGX301) is a novel photodynamic therapy using synthetic hypericin, activated by visible light, which has shown promising efficacy and safety in previous studies [3][4] - The FLASH2 study builds on the previous successful Phase 3 FLASH study, which demonstrated a 49% treatment response rate in patients completing 18 weeks of therapy [5][9] Clinical Study Design - FLASH2 is a randomized, double-blind, placebo-controlled, multicenter study that extends the treatment duration to 18 weeks without breaks, aiming to provide a more realistic assessment of HyBryte™'s efficacy [2][10] - The primary endpoint assessment will occur at the end of the 18-week treatment period, with the study replicating key design components from the first FLASH study [9][10] Regulatory Status - HyBryte™ has received orphan drug and fast track designations from the FDA, indicating its potential for expedited review due to the rarity of CTCL [4][12] - The FDA and EMA have indicated that a second successful Phase 3 trial is necessary for marketing approval, which the FLASH2 study aims to fulfill [9][10] Market Context - CTCL is a rare form of non-Hodgkin's lymphoma, affecting approximately 31,000 individuals in the U.S. and 38,000 in Europe, with limited treatment options available [13][14] - The safety profile of HyBryte™ is a significant advantage, as it avoids the risks associated with traditional therapies that can lead to severe side effects, including secondary malignancies [8][12]