Soligenix Updates United States Medical Advisory Board for Cutaneous T-Cell Lymphoma

Core Insights - Soligenix, Inc. is advancing the Phase 3 clinical development of HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin's lymphoma [1][20] - The company has updated its Medical Advisory Board (MAB) to include key opinion leaders in CTCL to provide strategic guidance as it progresses with clinical studies and regulatory interactions [2][3] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, including HyBryte™ for CTCL [20] - The company is also developing other products, including SGX302 for psoriasis and dusquetide (SGX942) for inflammatory diseases [20][21] Clinical Development - The FLASH Phase 3 trial enrolled 169 patients with Stage IA, IB, or IIA CTCL, demonstrating a 16% response rate for HyBryte™ compared to 4% for placebo in the first treatment cycle [10] - In the second treatment cycle, a 40% response rate was observed among patients receiving 12 weeks of HyBryte™ treatment, significantly higher than the placebo group [11] - The third optional treatment cycle showed that 49% of patients who received HyBryte™ throughout all cycles demonstrated a positive treatment response [12] Safety and Efficacy - HyBryte™ is noted for its safety profile, as it is not associated with DNA damage, making it a safer alternative to current therapies that have significant side effects [13] - The treatment has received orphan drug and fast track designations from the FDA, indicating its potential for addressing unmet medical needs [9][16] Regulatory Pathway - Following the first Phase 3 study, both the FDA and EMA require a second successful Phase 3 trial for marketing approval, which is currently ongoing [14] - The FLASH2 study aims to replicate the successful design of the first trial while extending the treatment duration to 18 weeks [14] Market Potential - CTCL affects approximately 31,000 individuals in the U.S. and 38,000 in Europe, with around 3,200 and 3,800 new cases annually, respectively [19] - The company anticipates accelerated enrollment in the FLASH2 study due to its engagement with the CTCL community and previous trial experiences [14]