Soligenix Initiates Confirmatory Phase 3 Clinical Trial of HyBryte™ for the Treatment of Cutaneous T-Cell Lymphoma

Core Viewpoint - Soligenix, Inc. has initiated patient enrollment for its confirmatory Phase 3 study, FLASH2, to evaluate HyBryte™ in treating cutaneous T-cell lymphoma (CTCL), building on previous successful studies [1][9]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, including HyBryte™ for CTCL [14]. - The company is also developing other products, including SGX302 for psoriasis and SGX942 for inflammatory diseases [14][15]. Product Details - HyBryte™ (SGX301) is a novel photodynamic therapy using synthetic hypericin activated by safe visible light, targeting malignant T-cells in CTCL [3][4]. - The treatment avoids risks associated with DNA-damaging drugs and has shown significant anti-proliferative effects on malignant T-cells [3][8]. Clinical Study Insights - The FLASH2 study will enroll approximately 80 subjects with early-stage CTCL, extending the treatment duration to 18 weeks of continuous therapy [2][9]. - In the previous Phase 3 FLASH study, a treatment response of 49% was observed in patients completing 18 weeks of therapy [5][9]. - The FLASH2 study aims to replicate the successful design of the first FLASH study while providing a more prolonged treatment assessment [9][10]. Regulatory and Funding Support - HyBryte™ has received orphan drug and fast track designations from the FDA and orphan designation from the EMA [4]. - The FDA awarded a $2.6 million Orphan Products Development grant to support the evaluation of HyBryte™ for early-stage CTCL treatment [11]. 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 no current cure available [12][13]. - The disease's treatment landscape is motivated by safety concerns, as existing therapies often have significant side effects [8].