Soligenix’s HyBryte achieves safety milestone in Phase 3 T-cell lymphoma trial

Soligenix’s (SNGX) first Data Monitoring Committee meeting for its confirmatory Phase 3 study evaluating HyBryte – synthetic hypericin – in the treatment of cutaneous T-cell lymphoma, or CTCL, has concluded that there are no safety concerns with the ongoing Phase 3 study and that HyBryte has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. The confirmatory Phase 3 FLASH2 study builds on the previous statistically significant Phase 3 FLASH study, as well as a recent successful comparative study and an ongoing investigator-initiated study supporting the design of the FLASH2 clinical trial. Soligenix anticipates providing an enrollment update in 4Q25 and supporting the DMC in undertaking a pre-specified blinded interim efficacy analysis in 1H26. In the first Phase 3 study, a treatment response of 49% was observed in patients completing 18 weeks of therapy. The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate the effect of HyBryte over a more prolonged, “real world” treatment course.