On December 16, 2024, Soligenix, Inc. (SNGX) announced it has opened patient enrollment for the confirmatory Phase 3 FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2) trial of HyBryte in patients with cutaneous T cell lymphoma (CTCL). This trial is supported by the statistically significant results from the Phase 3 FLASH study along with a successful comparator study and an ongoing investigator-initiated study. The trial will enroll approximately 80 patients across the U.S. and E.U. Patients will be treated for 18 consecutive weeks before being assessed for the study's primary endpoint. This is in contrast to the FLASH study, in which patients received three 6-week treatment cycles with two week breaks in between treatment cycles. This difference increases our confidence of a successful outcome to the FLASH2 trial. We anticipate updates on the trial's progress throughout 2025.
