Soligenix, Inc. provided an interim update on January 14, 2025, from an ongoing open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ treatment for early-stage cutaneous T-cell lymphoma (CTCL). The study, supported by a $2.6 million FDA Orphan Products Development Grant, has enrolled nine patients treated for up to 54 weeks.
Results indicate that over 70% (5 of 6 subjects who completed at least 18 weeks of therapy) achieved 'Treatment Success,' defined as a greater than or equal to 50% improvement in the cumulative mCAILS score. Notably, two patients achieved a 'complete response' by 18 weeks, demonstrating HyBryte's rapid action.
HyBryte™ continues to appear safe and well tolerated in all patients, reinforcing its benign safety profile observed across multiple clinical studies. These promising results further support the ongoing confirmatory Phase 3 FLASH2 study and HyBryte's potential as a safe and effective therapy for this chronic orphan disease.
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