Soligenix Achieves Enrollment Milestone for Planned Interim Analysis in Confirmatory Phase 3 Clinical Trial of HyBryte™ for the Treatment of Cutaneous T-Cell Lymphoma

Core Insights - Soligenix, Inc. has completed the enrollment of 50 patients for the interim analysis in its Phase 3 study of HyBryte™ for treating cutaneous T-cell lymphoma (CTCL) [1][2] - The interim analysis is expected to occur in the second quarter of 2026, with a planned overall blinded study response rate of 25% [2][10] - The study builds on previous successful trials, demonstrating a response rate of 48% among patients who have completed the treatment phase to date [2][4] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs [16] - The company is advancing HyBryte™ (SGX301), a novel photodynamic therapy utilizing synthetic hypericin, for the treatment of CTCL [16][3] - The company also has other development programs targeting conditions such as psoriasis and inflammatory diseases [16] Study Details - The FLASH2 study is a randomized, double-blind, placebo-controlled trial enrolling approximately 80 subjects with early-stage CTCL [2][10] - The study design replicates the first successful Phase 3 FLASH study, extending the treatment to 18 weeks without breaks [10][11] - Previous studies indicated a treatment response of 49% in patients completing 18 weeks of therapy in the first Phase 3 study [11][6] Treatment Efficacy - HyBryte™ has shown a response rate of 75% in an ongoing investigator-initiated study, with a benign safety profile observed [2][5] - The treatment has demonstrated significant anti-proliferative effects on malignant T-cells and has received orphan drug and fast track designations from the FDA [5][10] - The first Phase 3 study showed a statistically significant improvement in lesion reduction compared to placebo [6][7] 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 [15][14] - There is currently no approved front-line therapy for CTCL, making HyBryte™ a potentially safer and effective treatment option [9][14] - The FDA and EMA require a second successful Phase 3 trial for marketing approval, which Soligenix is currently pursuing with the FLASH2 study [10][19]