Soligenix(US:SNGX) Prnewswire·2024-06-25 11:30Core Insights - Soligenix's HyBryte™ shows promising results in treating cutaneous T-cell lymphoma (CTCL) compared to Valchlor®, with a higher percentage of patients achieving significant improvement in their condition [24][23][12] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, including HyBryte™ for CTCL [20][24] - The company is advancing its pipeline, which includes other therapeutic candidates for various conditions [20] Clinical Study Results - In a recent comparability study, 60% of patients treated with HyBryte™ achieved a ≥50% improvement in their modified Composite Assessment of Index Lesion Severity (mCAILS) score after 12 weeks, compared to 20% for Valchlor® [24][23] - The study involved 10 patients, with a favorable safety profile for HyBryte™, as no adverse events related to the therapy were reported, while 60% of Valchlor® patients experienced adverse events [2][24] Treatment Efficacy - HyBryte™ demonstrated a cumulative improvement in mCAILS of 52.5% compared to 34.7% for Valchlor® after 12 weeks [23] - The treatment was well tolerated across all patients, contrasting with Valchlor®, where one patient had to withdraw due to allergic contact dermatitis [23][2] Future Developments - Following the positive results, a second Phase 3 trial (FLASH2) is expected to begin before the end of 2024 to further evaluate HyBryte™ [6][12] - The FDA has granted an Orphan Products Development grant of $2.6 million to support the evaluation of HyBryte™ for expanded treatment options [7] Industry 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 [19][8] - The treatment landscape for CTCL is limited, with existing therapies often associated with significant side effects, highlighting the potential of HyBryte™ as a safer alternative [16][8]